KING EDWARD MEMORIAL HOSPITAL

Seth Gordhandas Sunderdas Medical College

Acharya Donde Marg, Parel,
Mumbai 400 012. India.
Tel.: 91-22-2410 7000 Fax: 91-22-2414 3435

Clinical Pharmacology

Courses Offered – 2022

  1. DM Clinical Pharmacology – 3 seats
  2. PhD Clinical Pharmacology- Maharashtra University of Health Sciences
  3. Fellowship in Drug Development – 2 seats- Maharashtra University of Health Sciences
  4. PhD – Applied Biology – Mumbai University
  5. MSc- Applied Biology – Mumbai University
  6. Two week hands training course in Therapeutic Drug Monitoring
  7. One week hands on training course in Adverse Drug Reactions Monitoring
  8. Undergraduate Certificate Course in Clinical Research- 35 seats

Observer Fees

Observor fees per month is Rs 3200/-. Payment to be made as CASH [Indian rupees] or via a Demand Draft in favor of ” BMC” to the cash section before 3 pm, Monday through Friday

Facilities, Equipments & Special services

Facilities

  • 40 bedded ward (of this 26 beds at the Kasturba Hospital for infectious diseases)
  • 3 bedded state of the art Phase 1 unit
  • Therapeutic Drug Monitoring lab and patient care services
  • Pharmacogenetics lab and patient care services

Standard Operating Procedures [SOPs]

Sr.No.  SOP
Index of SOP
SOP 01 Preparing Standard Operating Procedures (SOPs) for clinical trial related activities in the Department of Clinical Pharmacology, K. E. M. Hospital, Mumbai
SOP 02A Preparing the site team for a clinical study sponsored by a pharmaceutical company
SOP 02B Preparing the site team for an Investigator initiated clinical study
SOP 03 Responsibilities of the study team
SOP 04 Obtaining approval from the Institutional Ethics Committee
SOP 05 Administering and documenting written informed consent
SOP 06 Screening participants for participation in any clinical study
SOP 07 Recruitment of research participants.
SOP 08 Birth control measure for male participants
SOP 09 Birth control measures women participants.
SOP 10 Procedure for collection of blood samples of trial participants.
SOP 11 Dispensing investigational product
SOP 12 Source Documentation
SOP 13 Receipt, Inventory & Storage of IP
SOP 14 Adverse Event (AE) Monitoring, recording and Reporting
SOP 15 Serious Adverse Event (SAE) Monitoring, Recording & Reporting.
SOP 16 Established a Trial Master File (TMF)
SOP 17 Continued Interaction with the Institutional Ethics Committees
SOP 18 Archiving Documents
SOP 19 Preparing for Monitoring and Audit
SOP 20 Dealing with protocol deviations and violations in any clinical study
SOP 21 contact and communication with sponsor
SOP 22 storage and maintenance of IP
SOP 23 Return and Destruction of IP
SOP 24 Waste Management
SOP 25 Separation, storage and shipment of Blood samples
SOP 26 Internal Monitoring of Clinical studies
SOP 27 Audio Visual Consent Recording
SOP 28 Ensuring continuity of clinical trial in case staff & investigator attrition
SOP 29 Remote Monitoring

For Student

Awards & Honors

2021

  • First prize for best oral presentation. Title – Efficacy and safety of two doses of Ap-Bio®(Kalmcold®) in participants with uncomplicated upper respiratory tract viral infection (common cold) – A Phase III, double-blind, parallel group, randomized placebo-controlled trial. AUTHORS: Jeffrey Pradeep Raj1, Miteshkumar Maurya1, Nayana Nair1, Hetal Marfatia2, Rujuta Hadaye3, Nithya Jaideep Gogtay1.  Departments of 1Clinical Pharmacology, Otorhinolaryngology2, Community Medicine3 – Seth GS Medical College & KEM Hospital, at the annual conference of the Indian Society of Clinical Research [ISCR]
  • Second prize for best e poster. Title -An audit of studies registered for COVID-19 infection with the Clinical Trials Registry of India. Gunjal VS, Godbole CJ, Bendkhale S, Desai NN, Thatte UM, Gogtay NJ. Department of Clinical Pharmacology

2020

  • Second Prize [Oral Presentation] for “An audit of consent declines in Randomized Controlled Trials [RCTs] conducted in COVID-19 [and published] during a ten month period’, presented at FERCICON 2020.
  • Miss Shagun Nasta, undergraduate student won the first prize [oral presentation] at the 13th annual conference of the Indian Society of Clinical Research held in Mumbai from 23-25 Jan 2020 for her work on ” An audit of conflict of interest policies among Indian biomedical journals”

2019

  • Konwar M, Goel T, Gogtay NJ, Thatte UM. An Audit of Reporting of Black Box Warnings [BBWs] in United States Food and Drug Administration (US-FDA) Database. Third prize, poster presentation at the Undergraduate Students’ Conference CONFLUENCE, August 2019. Undergraduate student Tejusv Goel won the prize.
  • Maurya M, Konwar M, Bose D, Gogtay NJ, Thatte UM, Jamale T, Bajpai D, Hase NK. Association of CYP3A5 polymorphism with trough levels of Tacrolimus and graft outcomes in Indian renal transplant recipients. First prize, oral presentation at the Undergraduate Students’ Conference CONFLUENCE, August 2019. Second year DM resident Dr Mitesh Maurya won the prize.

2017

  • Awards won- 2017
  • 10 th and 11 th February 2017- At the 10 th annual meeting of the Indian Society for Clinical Research,Mumbai

Best paper award- oral presentations

1- Survey of Public Knowledge and Perceptions about Clinical Research in Mumbai [awarded to Ashnik Chauhan- undergraduate student]

2-Association between genetic polymorphisms of CYP2C9 & VKORC1 and safety & efficacy of Warfarin:
Results of a 5-year audit [awarded to Dr Mansij Biswas – Speciality Medical Officer]

Best paper award- poster presentations

1- A three year analysis of retracted articles from Pubmed indexed core clinical journals- [awarded to Dr Nayan Chaudhari, First year DM resident]

2- Do Clinical Trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India [CTRI]- [awarded to Dr Nithya Gogtay, Additional Professor]

2016

  1. First prize for best paper at the Indian Society for Clinical Research annual conference. Jan 2016. For the paper entitled ” Does audiovisual recording improve understanding among research participants” . Authors- Figer B, Chaturvedi M, Thaker S, Gogtay NJ, Thatte UM.
  2. An audit of approval letters issued by the Drug Controller General of India (DCGI) to the ethics committees in India. Authors: Bhide SS, Katkar JV,Maurya MR, Gogtay NJ,Thatte UM. Awarded the best poster at the annual meeting of the Indian Society of Clinical Research, Jan 2016

2015

  1. Best poster award at the WAME International Conference for Medical Journal Editors, New Delhi 1-4 October 2015.
    • Poster entitled ” An audit of randomized controlled trials [RCTS] published in two high impact factor journals in 2013 to assess compliance with CONSORT statement 2010. Authors- Gada P, Susvirkar A, Figer B, Gogtay NJ, Thatte UM

2014

  1. Mr Agastya Belur won the poster prize for Epidemiology session 1 at Groningen, Netherlands. Project title- The demographics of animal bite victims and management practices in a tertiary care institute in Mumbai. Poster presented at the 21st International Student Congress On (bio)Medical Sciences [ISCOMS, 2014]

2012

  1. KVPY award of the Department of Science and Technology, Government of India, for the year 2011, won by Miss Samruddhi Dani, 2nd MBBS (undergraduate student) for her work on ” Enhancing blood transfusion safety using haemovigilance”
  2. Kannan S et al. Association of genetic polymorphisms of CYP2C19, ABCB1, P2Y12 and Prakriti with response to clopidogrel. Best poster award at the monthly meeting of the staff society, March 2012.
  3. Taur S et al – 3rd Prize in poster- PG presentation in Staff Society Meeting – 27 Feb 2012 – “Pharmacogenomics of antiepileptic drugs: role of ABCB1, CYP2C9 and CYP2C19 in optimizing therapy”
  4. Momin S et al – 3rd prize in oral – PG presentation in Staff Society Meeting – 27 Feb 2012 – “Pharmacokinetics of primaquine in pediatric population” (study in collaboration with the Department of Pediatrics)

For Patient

Other

Centres

  • ICMR centre for Advanced Research in Clinical Pharmacology
  • WHO Special Centre for Adverse Drug Reactions Monitoring
  • DCGI Centre for Adverse Drug Reactions Monitoring
  • Central Drug Research Institute (CDRI) Clinical Pharmacology Unit
  • Integrated Systems of Medicine Research Centre
  • Liposome Clinical Pharmacology Centre, Govt. of India
  • Department of Biotechnology, Government of India Training centre for Clinical Research

Funding

  1. Municipal Corporation of Greater Mumbai.
  2. Indian Council of Medical Research (ICMR)
  3. World Health Organization
  4. Pharmaceutical Industries
  5. Department of Biotechnology, Govt of India
  6. Ministry of Health and Family Welfare, Govt of India (Pharmacovigilance grant)
  7. Program for Appropriate Technology (PATH)
  8. National Institutes of Health (NIH), Maryland, USA
  9. Other International Agencies- Johns Hopkins University
  10. Central Drug Research Institute, Lucknow

Faculty

Municipal Faculty

  • Dr. Nithya Gogtay – Professor and Head
  • Dr Mahesh Belhekar – Associate Professor
  • Dr Bhaskar Krishnamurthy- Assistant Professor
  • Dr. Urmila Thatte – Emeritus Professor
  •  Dr Antara Pohegaonkar-Registrar
Assistant Professors [serving bond]
  • Dr Jeffery Raj [joining date 28-9-2021]
  • Dr Shruti Saha [joining date 1-10-2021]
  • Dr Unnati Saxena [joining date 6-10-2021]
Visiting Faculty
  • Dr. Sunita Chhapola Shukla  – Consultant Allergologist
  • Dr Durga Gadgil – Consultant [Drug Development and Pharmaceutical Medicine]

Residents

Third year residents
  • Dr Vijaya L Chaudhari
  • Dr Palvi Kudyar
Second year residents
  • Dr Dhruve Soni
  • Dr Sukant Pandit
  • Dr Shakeeb Dhorajiwala

First year residents

  • Dr Ananya Rakshit
  • Dr Roopa Parida

Laboratory and Clinical Research Operations

  • Ms. Shital Bendkhale – Laboratory In Charge
Medical Officers – Clinical Pharmacology
  • Registrar- Post vacant
Staff working under the Indian Council of Medical Research [ICMR] Product Development Center
  • Senior Research Fellow – Position vacant
  • Laboratory Technician – Position vacant
  • Laboratory Technician- Position vacant
  • Data Entry Operator- Position vacant
  • Laboratory Attendant- Position vacant
  • Laboratory Attendant- Position vacant

Staff working under INCENTIVE FLU project – Department of Biotechnology, Govt of India
  • Scientific Admin Assistant – Vaishali Hadikar
  • Scientific Admin Assistant – Sayali Shirkar
  • Scientific Admin Assistant – Post vacant
  • Senior Medical Officer- Post vacant
  • Against Junior Medical Officer- Sheetal Kudtarkar

Office Secretary

  • Mrs Ujwala Parulekar

Executive Assistants

  • Mr Nimish Rane

Departmental Alumni

Name Batch Current Position according to LinkedIn/Facebook Previous Positions according to LinkedIn/Facebook
Dr. Balaji More 2001 Vice President – Medical at Raptakos Brett & Co, Mumbai 1.    Assistant General Manager in Cadila Pharmaceuticals, Ahmedabad (2013-15)

2.    Head, Medical Affairs, Merck Serono India (2010-2013)

3.    Head – Medical Services,Shreya Life Sciences Pvt. Ltd, Mumbai (2010)

4.    Senior Research Scientist, Wockhardt, Mumbai (2007-10)

5.    Head, Medical Services, Stiefel, GSK (2005-07)

Dr. Sanath Hegde 2002 Currently in Singapore Novartis India Pvt Ltd.
Dr. Sanish Davis 2002 Country Head,India

and Senior Medical Director, Scientific & Medical Affairs, CVMER at Covance Pharamceutical Services Pvt. ltd.

1.      Director- Clinical Pharmacology, MSD (2012-14)

2.      Deputy General Manager, Clinical Research (Drug Discovery) Glenmark Pharmaceuticals (2010-12)

3.      Head, Business Operations at Country Clinical Operations, Pfizer Ltd (2010)

4.      Manager, Clinical Research, Pfizer Ltd (2008-10)

5.      Medical Advisor, Pfizer Ltd (2007-08)

6.      Clinical Pharmacologist, Zydus Cadila(2006-07)

7.      Clinical Pharmacologist and Project Manager, Clinical R&D (2006-07)

Dr. Priti D. Costa 2007 Pharmacovigilance, TCS
Dr. Suresh K Ramakrishna 2008 Associate Professor,

Davangere Medical College

Assistant Professor, Department of Clinical Pharmacology, TNMC & BYL Nair Hospital, Mumbai
Dr. Santosh Taur 2009 Manager, Medical Affairs, Pfizer Ltd. 1.      Manager – Medical and Regulatory Affairs, South Asia – Galderma India Pvt. Ltd.(2014-16)

2.      Assistant Professor,

Department of Clinical Pharmacology, BYL Nair Hospital, Mumbai

(2013 – 14)

Dr. Kannan Sridharan 2009 Associate Professor,

Department of Pharmacology and Therapeutics, College of Medicine and Medical Sciences, Arabian Gulf University, Manama, Bahrain.

1.      Associate Professor, Fiji National University, Suva, Fiji

2.      Assistant Professor of Pharmacology at Medical College, Meerut

3.      Assistant Professor,

Department of Clinical Pharmacology, KEM Hospital, Mumbai (2013 – 14)

Dr. Maulik Doshi 2010 Deputy General Manager,

Sun Pharmaceuticals, Mumbai

(Apr 2016 – Present)

1.      Manager, Sun Pharmaceuticals, Mumbai (Nov 2014- Mar16)

2.      Assistant Professor,

Department of Clinical Pharmacology, KEM Hospital, Mumbai

(2013 – 14)

Dr. Saket Thacker 2011 Senior Manager (Clinical Strategy)

Dr. Reddy’s Laboratories

(Mar 2017 – Present)

​1​

.      Medical Monitor,Roche Products Pvt Ltd, India (Oct 2015- Mar 17)

​2​

.      Assistant Professor,Department of Clinical Pharmacology, KEM Hospital, Mumbai

(Oct 14 – Sept 15)

PhD students

  • Ms Shital Bendkhale
  • Mrs Prajakta Gandhe
  • Shri Nitin Mali
  • Shri Prashant Kadam
  • Ms Charulata Godbole
  • Dr Mahesh Belhekar
  • Dr Shantanu Joshi

MSc students:

  • Mrs. Mukta Kuyare

Protocol for systematic review for the use of deception in clinical research

PATENT

  • Srivastava S, Patankar S, Ray S, Thatte U, Gogtay N, Durairaj R, Dikshit J, Subramanian K et al. Protein markers for Plasmodium vivax malaria, application number 2195/MUM/2012, under Indian Patents Act [1970] along with Indian Institute of Technology, Bombay

Recent Publications

YEAR-2022

  1. Jeffery Pradeep Raj, Nithya J Gogtay, Avaneesh Pandey, Ashish Kumar Kakkar, Nusrat Shafiq Khan, Mekala Padmaja, Usharani Pingali, Arun Prasath Raju, Surulivelrajan Mallayasamy, Nilima Arun Kshirsagar. Population pharmacokinetics of hydroxychloroquine sulphate in healthcare workers given for prophylaxis against Corona Virus Disease 2019 (COVID-19) in India”. The J Clinical Pharmacol 2022; 0(0): 1-9.
  2. Karande S, Bhavani S, Gogtay NJ, Shiledar MP, Kelkar S, Oke AS. Do school students with specific learning disabilities have lower emotional intelligence abilities? A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India. J Postgrad Med 2022;68:24-30.
  3. Saha S, Gogtay NJ. Research, residents, and registrars – getting it right. Perspect Clin Res 2022; 3(2):63-64.
  4. Raj JP, Mamde A, Ganatra K, Gogtay NJ, Thatte UM. An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals. Perspectives in Clinical Research 2022; 13(3): 172-73.
  5. Konwar M, Mamde A, Patankar P, Thatte UM, Gogtay NJ. An audit of safety reporting in randomized controlled trials over a five–year period in a high impact factor journal. J Postgrad Med; 2022;68:133-7

YEAR-2021

  1. Figer BH, Lamture SS, Gandhi T, Chauhan A, Gvalani A, Gogtay NJ, et al. A survey of knowledge and variables influencing perceptions about clinical research: A cross-sectional study from Mumbai. Perspect Clin Res 2021;12:93-9
  2. Shetty NS, Salvi RA, Thatte UM, Gogtay NJ. Has mandatory prospective registration of all studies brought about a change? A 1-year audit of studies registered in the Clinical Trials Registry of India [CTRI] before and after April 1, 2018. Perspect Clin Res 2021;12:72-5.
  3. Gogtay NJ, Ranganathan P, Aggarwal R. Understanding estimands. Perspect Clin Res 2021;12:106-12.
  4. Bose D, Gogtay NJ, Rajan SK. Placing the results of the SOLIDARITY trial with regards to Remdesivir in perspective – Lung India [accepted for publication]
  5. Bavdekar SB, Saha S, Thatte UM, Gogtay NJ. An analysis of invitations for article submissions received via e mail. Accepted for publication in the Indian Jr Medical Ethics
  6. Konwar M, Maurya MM, Thatte UM, Gogtay NJ, Bose D. A systematic review and meta analysis of the safety of Hydroxychloroquine in randomized controlled trials and observational studies. Accepted for publication in Current Clinical Pharmacology
  7. Gogtay NJ, Sheth HJ, Maurya MM, Belhekar MB, Thatte UM. A literature review of consent declines and consent withdrawals in Randomized Controlled Trials (RCTs) conducted during the COVID-19 pandemic. Accepted for publication in the Journal of Postgraduate Medicine.
  8. Konwar M, Mamde A, Patankar P, Thatte UM, Gogtay NJ. An audit of safety reporting in randomized controlled trials over a five year period in a high impact factor journal. Accepted for publication in the Journal of Postgraduate Medicine.
  9. Bose D, Ravi RS, Gogtay NJ, Thatte UM, Borse T. An Audit of Interim Analyses of Randomized Controlled Trials [RCTs] Published in Three High Impact Factor Medical Journals over a seven-year period [2012-2018]. Accepted for publication in Reviews on Recent Clinical Trials.  
  10. Saxena U, Bose D, Saha S, Gogtay NJ, Thatte UM. An Audit of Warning letters [WLs] issued to Sponsors, Institutional Review Boards [IRBs], and Investigators by the United States Food and Drug Administration (US FDA) over a six-year period. Accepted for publication in the Indian Jr Medical Ethics
  11. Konwar M, Gogtay NJ, Ravi R, Thatte UM, Bose D. Evaluation of efficacy and safety of Fosfomycin versus Nitrofurantoin for the treatment of uncomplicated lower urinary tract infection (UTI) in women – A systematic review and meta – analysis. Accepted for publication in Journal of Chemotherapy. 
  12. Subash S, Gogtay NJ, Iyer KR, Gandhe P, Budania R, Thatte UM. Evaluation of vanillin as a probe drug for aldehyde oxidase and phenotyping for its activity in a Western Indian cohort. Indian J Pharmacol 2021;53:213-20.
  13. Konwar M, Maurya MR, Nishandar TB, Thatte UM, Gogtay NJ. An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018). Perspect Clin Res 2021;12:159-64.
  14. Raj Jeffery, Mamde AM, Ganatra K, Gogtay NJ & Thatte UM. An evaluation of minutes of subject expert committee [SEC] meetings of novel corona virus disease [COVID-19] proposals. Accepted for publication in Perspectives in Clinical Research.
  15.  Shukla SC, Pandit S, Soni D, Gogtay NJ. Evaluation of allergic reactions following COVID-19 vaccination in patients with documented allergies. J Assoc Phy Ind 2021; 69: 14-17.
  16. Chaudhari VL, Godbole CJ, Bendkhale SB, Desai NN, Gogtay NJ, Thatte UM. Evaluation of COVID-19 studies registered with Clinical Trials Registry of India [CTRI]- a database analysis. J Assoc Phy Ind 2021; 69: 28-31.
  17. Gogtay NJ and Bhatt AD. The clinician and the pandemic- keeping track, keeping pace and keeping the faith. J Assoc Phy Ind 2021; 69: 11-12.
  18. Karande S, Bhavani S, Gogtay NJ, Shiledar MP, Kelkar S, Oke AS. Do school students with specific learning disabilities have lower emotional intelligence abilities? A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India. J Postgrad Med 2022;68:24-30.

YEAR-2020

  1. Chaudhari N, Ravi R, Gogtay NJ, Thatte UM. Recruitment and retention of participants in Clinical Trials: Challenges and Solutions. Accepted for Publication in Perspectives in Clinical Research
  2. Saha S, Kerkar P, Gogtay NJ. A critical analysis of the non – inferiority design of the TALENT trial. Accepted for publication in the Indian Heart Journal.
  3. Gogtay N, Kuyare M, Pai N, Mehta L, Rajapure P, Thatte U. A randomized, controlled, equivalence study of authorized versus non – authorized deception in a model of pain following third molar extraction. Accepted for publication in Clinical Ethics. SAGE publications 2020;
  4. Gogtay NJ, Thatte UM. Sampling and Sample Size in Clinical Research – A Scientific and Ethical Imperative. J Assoc Phy Ind 2020; 68: 11-12.
  5. Rajan S, Gogtay NJ, Konwar M, Thatte UM. The global initiative for asthma guidelines (2019): change in the recommendation for the management of mild asthma based on the SYGMA-2 trial – A critical appraisal. Lung India 2020; 37(2):169-173.
  6. Figer B, Gogtay NJ, Thatte UM. Compliance of Mumbai based Clinical Trial Sites with the Quality Council of India [QCI] guidelines and evaluation of the challenges faced by the investigators. Accepted for publication in Perspectives in Clinical Research.
  7. Figer BH, Sapra KP, Gogtay NJ, Thatte UM. A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies. Perspect Clin Res 2020;11:13-7.
  8. Bose D, Saha S, Saxena U, Kesari H, Thatte UM, Gogtay NJ. Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit. Perspect Clin Res 2020;11:81-5.
  9. Chaudhari N, Ravi R, Gogtay NJ, Thatte UM. Recruitment and retention of the participants in clinical trials: Challenges and solutions. Perspect Clin Res 2020;11:64-9.
  10. Godbole C, Thaker S, Kerkar P, Nadkar M, Gogtay NJ, Thatte UM. Association of Paraoxonase 1 (PON1) gene polymorphisms and enzymatic activity on risk of coronary artery disease (CAD)” . Accepted for publication in Future Cardiology.
  11. Ranganathan P, Nair D, Gogtay NJ. Addressing challenges due to the COVID-19 pandemic – A site and investigator perspective. Perspect Clin Res 2020;11:111-4.
  12. Saxena U, Bose D, Maurya M, Gogtay NJ, Thatte UM. An audit of questions asked by participants during the informed consent process for regulatory studies at a tertiary referral centre – an analysis of consent narratives. Accepted for publication in Clinical Ethics.
  13. Figer BF, Raj JP, Thaker SP, Gogtay NJ, Thatte UM. Determination of Reference Intervals from a Laboratory Database of an Academic Clinical Research Unit Affiliated to a Tertiary Care Teaching Hospital and an Audit of Out of Range Values. Accepted for publication in Perspectives in Clinical Research [PICR].
  14. Dhuya M, Pal MM, Hazra A, Chaterjee S, Gogtay N. Cytochrome P450D6 polymorphism in eastern Indian population. Ind J Pharmacol 2020; 52: 189-95. 
  15. Bacchav SS, Dighe V, Mali N, Gogtay NJ, Thatte UM, Devarajan PV. Nose to brain delivery of diazepam from an intra nasal aqua-triggered in – situ [ATIS] gelling microemulsion: monitoring brain uptake by micro dialysis. Eur J Drug Metabolism and Pharmacokinetics. Published on line on 19 Aug 2020.
  16. Bose D, Nasta S, Ravi R, Thatte UM, Gogtay NJ. An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals. Perspect Clin Res 2020;11:168-73.

YEAR-2019

    1. Shetty PA, Gogtay NJ & Thatte UM. An audit of minutes of Subject Expert Committee [SEC] meetings as a metric to assess the clinical research roadmap of India. Perspect Clin Res 2019; 10: 15-19.
    2. Birajdar AR, Bose D, Nishandar TB, Shende AA, Thatte UM & Gogtay NJ. An audit of studies registered retrospectively with the Clinical Trials Registry of India [CTRI] – a one-year analysis. Accepted for publication. Perspect Clin Research 2019; 10: 26-30.
    3. Mukhopadhyay S, Tiwari P, Sekharan S, Shetty P, Gogtay NJ, Thatte UM. Modelling and Forecasting Indian Malaria Incidence Using Generalized Time Series Models. Accepted for publication in Communications in Statistics – Case Studies and Data Analysis.
    4. Gogtay NJ. Reporting of Randomized Controlled Trials: will it ever improve? Accepted for publication in Perspectives in Clinical Research. [Editorial].
    5. Shah I, Jadhao N, Mali N, Deshpande S, Gogtay N, Thatte U. Pharmacokinetics of isoniazid in Indian children with tuberculosis on daily treatment. Int J Tuberc Lung Dis 2019; 23 (1): 52-7.
    6. Bose D, Saha S, Saxena U, Kesari H, Thatte UM, Gogtay NJ. Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center- a five year audit. Accepted for publication in Perspectives in Clinical Research. [Original article].
    7. Kannan S, Sannala CR, Mallaysamy SR, Chaturvedi A, Kadam PK, Hase NK, Shukla A, Gogtay N, Thatte UM. Population pharmacokinetics of primaquine in Indian population and effect of hepatic dysfunction- an exploratory approach.  Indian J Pharmacol 2019; 51: 17-24.
    8. Bose D, Saha S, Saxena U, Kesari H, Thatte UM, Gogtay NJ. Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit. Perspect Clin Res [Epub ahead of print] [cited 2019 May 4]. DOI: 10.4103/picr.PICR_198_18
    9. Sengar M, Gogtay N, Jain H. Ibrutinib Regimens in Older Patients with Untreated CLL. N Engl J Med. 2019; 25;380(17):1679.
    10. Shukla A, Jain A, Kahalekar V, Bendkhale S, Gogtay N, Thatte U, Bhatia S. Mutations in CYP2C9 and/or VKORC1 haplotype are associated with higher bleeding complications in patients with Budd-Chiari syndrome on warfarin. Hepatol Int 2019; 13(2):214-221.#
    11. Mali NB, Tullu MS, Wandalkar PP, Deshpande SP, Ingale VC, Deshmukh CT, Gogtay NJ, Thatte UM. Steady state pharmacokinetics of vancomycin in children admitted to the Pediatric Intensive Care Unit of a tertiary referral center. Indian Jr Critical Care Medicine 2019; 23: 497-502.

YEAR-2018

  1. Karande S, Gogtay NJ, Bala N, Sant H, Thakkar A, Sholapurwala R. Anxiety symptoms in regular school students in Mumbai City, India. J Postgrad Med. 2018;64:92-7.
  2. Shetty PA, Maurya M, Figer BH, Thatte UM & Gogtay NJ. Audiovisual recording of the consenting process in clinical research: experiences from a tertiary referral centre. Perpect Clin Res 2018; 9: 44-7.
  3. Gogtay NJ, Bose D, Thatte UM. Sotagliflozin as add on therapy to insulin in patients with Type 1 diabetes. [letter to editor]. New Engl J Med 2018; 378:966-968 DOI: 10.1056/NEJMc1800394
  4.  Biswas M, Bendkhale S, Deshpande S, Thaker S, Kulkarni D, Bhatia S, Rajadhyaksha A, Gogtay NJ, Thatte UM. Association between genetic polymorphisms of CYP2C9 and VKORC1 and safety and efficacy of warfarin: results of a 5 years audit. Indian Heart Journal.httpss://doi.org/10.1016/j.ihj.2018.02.005
  5. Birajdar AR, Bose D, Nishandar TB, Shende AA, Thatte UM & Gogtay NJ. An audit of studies registered retrospectively with the Clinical Trials Registry of India [CTRI] – a one-year analysis. Accepted for publication. Perspect Clin Research.
  6.  Thatte UM, Gogtay NJ. Traditional Medicine: A review of work in India [2012-17]. Proceedings of the Indian National Science Academy, 2018. pp 267-279.
  7.  Gogtay NJ. Research methodology workshops – a small step towards the practice of Evidence Based Medicine. Perspec Clin Res 2018; 9: 59-60. [Editorial]
  8. Ravi R, Bose D, Gogtay NJ, Thatte UM. Investigator preparedness for monitoring and audits. Perspect Clin Res 2018; 9: 95-98.
  9. Marathe PA, Tripathi RK, Shetty YC, Kuyare SS, Kamat SK, Thatte UM. Payment for participation in clinical research- a review of proposals submitted to the ethics committee. Perspect Clin Res 2018; 9: 64-9.
  10. Gogtay NJ, Munshi R, Ashwath Narayana DH, Mahendra BJ, Kshirsagar V, Gunale B, Moore S, Cheslock P, Thaker S, Deshpande S, Karande S, Kumbhar D, Ravish HS, Harish BR, Pisal SS, Dhere R, Parulekar V, Blackwelder WC, Molrine DC, Kulkarni PS. Comparison of a novel, human rabies monoclonal antibody to Human Rabies Immunoglobulin for postexposure prophylaxis: a Phase 2/3 randomized, single-blind, non-inferiority, controlled study. Clin Infect Dis 2018; 18; 66(3):387-395.
  11. Ravi R, Mulkalwar A, Thatte UM & Gogtay NJ. Adherence of Medical Case Reports Published In 2015 In PubMed Indexed Indian Journals To CARE 2013 Guidelines. Accepted for Publication. Indian Journal of Medical Ethics.
  12. Kerkar P, Bose D, Nishandar T, Sabnis G, Kumar D, Thatte UM, Gogtay NJ. A critical analysis of the COMPASS trial with respect to benefit – risk assessment using the number needed to treat [NNT]:-applicability and relevance in Indian patients with stable cardiovascular disease. Accepted for publication. Indian Heart Journal.
  13.  Mali NB, Deshpande SP, Tullu MS, Deshmukh CT, Gogtay NJ, Thatte UM. A prospective antibacterial utilization study in pediatric intensive care unit of a tertiary referral center. Indian J Crit Care Med 2018;22:422-6.
  14. Figer BH, Thaker SJ, Boob M, Gogtay NJ, Thatte UM. An evaluation of reporting of consent declines in three high impact factor journals. Accepted for publication in “Clinical Ethics”.
  15. Mahajan MM, Thatte UM, Gogtay NJ, Deshpande S. An analysis of completeness and quality of adverse drug reaction reports at an adverse drug reaction monitoring centre in Western India. Perspect Clin Res 2018;9:123-6.
  16. Birajdar AR, Thatte UM & Gogtay NJ. Procalcitonin – guide antibiotic usage- addressing heterogeneity in meta- analysis. Indian J Med Res 2018; 148(3): 348-349.
  17. Patgaonkar M, Herbert F, Powale K, Gandhe P, Gogtay N, Thatte U, Pied S, Sharma S, Pathak S.Vivax infection alters peripheral B-cell profile and induces persistent serum IgM. Parasite Immunol. 2018 Aug 13:e12580. doi:10.1111/pim.12580.
  18. Susvirkar A, Gada P, Figer B, Thaker S, Thatte UM, Gogtay NJ. An assessment of compliance of randomized controlled trials in two high impact factor journals with the CONSORT statement. Nat Med J Ind 2018; 31(2): 79-82.

YEAR-2017

    1. Gogtay NJ, Thatte UM. Survival analysis. J Assoc Phy Ind 2017; 65: 80-84
    2. Gogtay NJ, Deshpande SP, Thatte UM. Principles of regression analysis. J Assoc Phy Ind 2017; 65: 48-52.
    3. Gogtay NJ, Thatte UM. Principles of correlation analysis. J Assoc Phy Ind 2017; 65: 78-81.
    4. Gogtay NJ, Renju Ravi, Thatte UM. Regulatory requirements for clinical trials in India” what academicians need to know. Indian J Anaesth 2017; 61: 192-9.
    5. Thaker SJ, Gandhe PP, Godbole CJ, Bendkhale SR, Mali NB, Thatte UM, Gogtay NJ. A prospective study to assess the association between genotype, phenotype, and Prakriti in individuals on phenytoin monotherapy. Journal of Ayurveda and Integrative Medicine 2017; [xxx] 1-5. In press.
    6. Gogtay NJ, Thatte UM. Statistical evaluation of Diagnostic tests- part 1. J Assoc Phy Ind 65; 80-4
    7. Gogtay NJ, Thatte UM. Statistical evaluation of Diagnostic tests-part 2. J Assoc Phy Ind 65; 86-91.
    8. Ray S, Patel KS, Venkatesh A, Chatterjee G, Ansari NN, Gogtay NJ, Thatte UM et al. Quantitative proteomic analysis of Plasmodium vivax induced alterations in human serum during the acute and convalescent phases of infection. Scientific Reports 2017; 7: 4400/DOI: 10.1038/S41598-017-04447-5
    9. Gogtay NJ, Thatte UM. Number needed to treat. J Assoc Phy Ind 2017; 65: 90-4
    10. Kshirsagar NA, Gogtay NJ, Garg BS, Deshmukh PR, Rajgor DD, Kadam VS, Thakur PA, Gupta A, Ingole NS, Lazdins-Helds JK. Efficacy and tolerability of treatment with single doses of diethylcarbamazine (DEC) and DEC plus albendazole (ABZ) for three consecutive years in lymphatic filariasis: a field study in India. Parasitol Res 2017;Aug 7. doi: 10.1007/s00436-017-5577-9.
    11. Wandalkar P, Gandhe P, Pai A, Limaye M, Chauthankar S, Gogtay NJ, Thatte UM. A study comparing trial registry entries of randomized controlled trials with publications of their results in a high impact factor journal: The Journal of the American Medical Association. Perspect Clin Res 2017;8:167-71.
    12. Chaturvedi M, Gogtay NJ, Thatte UM. Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India. Perspect Clin Res 2017;8:172-5.
    13. Gogtay NJ, Thatte UM. An Introduction to Meta-analysis. J Assoc Phy Ind 2017; 65: 78-85.
    14. Figer BH, Chaturvedi M, Thaker SJ, Gogtay NJ & Thatte UM. A comparative study of the informed consent process with or without Audiovisual recording. Nat Med Jr Ind 2017; 30(5): 262-5.

Accepted for Publication

      1. Ray S, Patel SK, Venkatesh A, Chatterjee G, Ansari NN, Gogtay NJ, Thatte UM et al. Quantitative proteomics analysis of Plasmodium vivax induced alterations in human serum during the acute and convalescent phases of infection. Accepted for publication in Scientific Reports
      1. Susvirkar A, Gada P, Figer B, Thaker S, Thatte UM and Gogtay NJ. An assessment of the compliance of the Randomized Controlled Trials [RCTs] published in two high impact factor journals in 2013 with CONSORT statement 2010. Nat Med J Ind 2017; in press.
    1. Mahajan M,  Deshpande S, Gogtay NJ, Thatte UM. An analysis of completeness and quality of adverse drug reaction reports at an Adverse Drug Reaction monitoring centre in Western India’. Accepted for publication in Perspectives in Clinical Research.

YEAR-2016

    1. Jalgaonkar SV, Bhide SS, Tripathi RK, Shetty YC, Marathe PA, Katkar J, Thatte UM (2016) An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital. PLoS ONE 11(1): e0146334. doi:10.1371/ journal.pone.0146334
    2. S. Kannan, T. Modi, S. Bendkhale, D. Kulkarni, N.J. Gogtay and U.M. Thatte Bentham Science Publishers Association of Genetic Polymorphisms of CYP2C9 and VKORC1 with Bleeding Following Warfarin: A Case-control Study,* Current Clinical Pharmacology, 11, 000-000 1 1574-8847/16
    3. Gogtay NJ, Kapileshwar SR, Shah SU, Bendkhale SR, Ramakrishna S, Sridharan K, Thelma BK, Thatte UM & Kshirsagar NA.
      Evaluation of Cytochrome CYP2E1 polymorphisms in healthy, adult Western Indians and patients with antituberculous drug-induced hepatotoxicity. Indian J Pharmacol 2016; 4891): 42-6.
    4. Gogtay NJ, Sridharan K. Therapeutic Nucleic Acids- current clinical status. B J Clin Pharmacol 2016; April 25, ahead of print
    5. Gogtay NJ. Adieu… J Postgrad Med 2016; 62: 67-8
    6. Bhide SS, Jalgaonkar SV, Katkar JV, Shetty YC, Tripathi RK, Marathe PA, Thatte UM. Impact of recent regulatory notifications on an institutional ethics
      committee. Indian J Med Ethics. 2016 Jun 19;-(-):1-5. [Epub ahead of print]
    7. Tripathi RK, Marathe PA, Kapse SV, Shetty YC, Kamat SK, Thatte UM. Serious Adverse Events Reports: Analysis and Outcome of Review by an Institutional Ethics Committee of a Tertiary Care Hospital in Mumbai, India. J Empir Res Hum Res Ethics. 2016 Jun 27.[Epub ahead of print]
    8. Hazra A, Gogtay N. Biostatistics Series Module 3: Comparing Groups: Numerical
      Variables. Indian J Dermatol. 2016 May-Jun;61(3):251-60
    9. Ray S, Patel SK, Venkatesh A, Bhave A, Kumar V, Singh V, Chatterjee G, Shah
      VG, Sharma S, Renu D, Nafis N, Gandhe P, Gogtay N, Thatte U, Sehgal K, Verma S,
      Karak A, Khanra D, Talukdar A, Kochar SK, S B V, Kochar DK, Rojh D, Varma SG,
      Gandhi MN, Srikanth R, Patankar S, Srivastava S. Clinicopathological Analysis and
      Multipronged Quantitative Proteomics Reveal Oxidative Stress and Cytoskeletal
      Proteins as Possible Markers for Severe Vivax Malaria. Sci Rep. 2016 Apr
      19;6:24557
    10. Hazra A, Gogtay N. Biostatistics Series Module 2: Overview of Hypothesis Testing. Indian J Dermatol. 2016 Mar-Apr;61(2):137-45
    11. Hazra A, Gogtay N. Biostatistics Series Module 1: Basics of Biostatistics. Indian J Dermatol. 2016 Jan-Feb;61(1):10-20
    12. Gogtay NJ, Thatte UM. Clinical research- a primer. J Assoc Phy Ind 2016; 64: 62-63.
    13. Deshpande S, Gogtay NJ, Thatte UM. Data Types. J Assoc Phy Ind 2016; 64: 64-65.
    14. Deshpande S, Gogtay NJ, Thatte UM. Measures of central tendency and dispersion. J Assoc Phy Ind 2016; 64: 64-66.
    15. Gogtay NJ, Deshpande SP, Thatte UM. Normal distribution, p value and confidence intervals. J Assoc Phy Ind; 64:
    16. Gogtay NJ and Thatte UM. Samples and their size – the bane of researchers [Part I]. J Assoc Phy Ind 2016; 64: 66-69
    17. Gogtay NJ and Thatte UM. Samples and their size – the bane of researchers [Part II]. J Assoc Phy Ind 2016; 64: 68-71.

    YEAR-2015

    1. Thatte U, Chiplunkar S, Bhalerao S, Kulkarni A, Ghungralkar R, Panchal F, Vetale S, Teli P, Kumbhar D, Munshi R. Immunological & metabolic responses to a therapeutic course of Basti in obesity. Indian J Med Res. 2015 Jul;142(1):53-62. doi: 10.4103/0971-5916.162099.
    2. Lalwani S, Agarkhedkar S, Gogtay N, Palkar S, Agarkhedkar S, Thatte U, Vakil H, Jonnalagedda R, Pedotti P, Hoyle M, Bhusal C, Arora A. Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years. Int J Infect Dis. 2015 Sep;38:36-42. doi: 10.1016/j.ijid.2015.07.003. Epub 2015 Jul 9.
    3. Bavdekar SB, Gogtay NJ.
      Writing an abstract for a research manuscript: providing an honest, succinct and complete summary. J Assoc Phy Ind 2015; 63: 64-7.
    4. Thakkar AN, Karande S, Bala N, Sant H, Gogtay NJ, Sholapurwala R.
      Is anxiety more common in school students with newly diagnosed specific learning disabilities? A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India.
      J Postgrad Med. 2015 Oct 20. doi: 10.4103/0022-3859.167663. [Epub ahead of print] PubMed PMID: 26482116.
    5. Gogtay NJ & Ferner RE. Mefloquine for malarial prophylaxis in military personnel. BMJ 2015; 351: h5797
    6. Thaker SJ, Figer B, Gogtay NJ, Thatte UM. An audit of consent refusals in clinical research at a tertiary care centre in India. J Postgrad Med 2015; 61: 257-63.
    7. Ranganathan P, Gogtay NJ. Improving peri-operative patient care: the surgical safety checklist. J Postgrad Med 2015; 61: 73-4.
    8. Ray S, Kumar V, Bhave A, Singh V, Gogtay N, Thatte U, Talukdar A, Kochar SK,Patankar S, Srivastava S. Proteomic analysis of Plasmodium falciparum induced alterations in humans from different endemic regions of India to decipher malaria pathogenesis and identify surrogate markers of severity. J Proteomics. 2015 May 14. pii: S1874-3919(15)00232-8. doi:10.1016/j.jprot.2015.04.032. [Epub ahead of print]
    9. Thaker SJ, Sinha RS, Gogtay NJ & Thatte UM. Evaluation of inter rater agreement between three causality scales used in Pharmacovigilance” Jr Pharmacol PharmacoTher – accepted for publication.
    10. Jasani B, Kannan S, Nanavati R, Gogtay NJ & Thatte UM. An Audit of Colistin Use in Neonatal Sepsis from a Tertiary Care Centre of a Resource Limited Country. Ind Jr Med Res 2015; accepted for publication.
    11. Kuyare, MS, Marathe, PA, Kuyare, SS and Thatte UM. Perceptions and Experiences of Community Members Serving on Institutional Review Boards: A Questionnaire Based Study. HEC Forum; 20 Jan 2015
    12. Sengupta A, Ghosh S, Pathak S, Gogtay N, Thatte U, Doshi M, Sharma S, Sonawat H. Metabolomic analysis of urine samples of vivax malaria in-patients for biomarker identification. Metabolomics March 2015. DOI 10.1007/s11306-015-0791-x

    YEAR-2014

      1. Kuyare SS, Marathe PA, Shetty YC, Kamat SK, Katkar JV, Thatte UM “Projects Not Initiated by Investigators: A Retrospective Analysis of the Queries Raised by the Institutional Ethics Committees of a Teaching Hospital” J Postgrad Med. January-March; Volume 60(1):46-50
      2. Yadav S, Kannan S, Vaideeswar P, Gogtay N, Thatte U. Indian J Pathol Microbiol. 2014 Jan-Mar;57(1):152-3.
      3. SR Taur, NB Kulkarni, PP Gandhe, BK Thelma, SH Ravat, NJ Gogtay, UM Thatte. Association of polymorphisms of CYP2C9, CYP2C19, and ABCB1, and activity of P-glycoprotein with response to anti-epileptic drugs. Journal of Postgraduate Medicine, 60(3): 265-269.
      4. Kuyare MS, Taur SR, Thatte UM Establishing Institutional Research Ethics Committees: Challenges and Solutions – A Review of Literature. Indian Journal of Medical Ethics, 11(3): 181-185.
      5. Kannan S, Gogtay N, Thatte UM. Interaction of calcium channel blockers and grapefruit juice in healthy adults (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 12. Art. No.: CD011452. DOI: 10.1002/14651858.CD011452.
      6. Taur SR, Karande S, Saxena AA, Gogtay NJ, Thatte UM. Use of computerized tests to evaluate psychomotor performance in children with specific learning disabilities in comparison to children without any learning disability. Indian Journal of Medical Research, 140, November 2014, pp 644-648
      7. Gogtay NJ, Nagpal A, Mallad A, Patel K, Stimpson SJ, Belur A & Thatte UM. Cost calculations in health care- a reply. Ind Jr Med Res 2014; 140: 568-69.
      8. Bang V, Mallad A, Kannan S, Bavdekar SB, Gogtay NJ, Thatte UM. Awareness about and views of parents on off label drug use in children. Int J Risk Saf Med. 2014 26(2):61-70.
      9. Karande S & Gogtay NJ. Impact of the midday meal scheme in India. J Postgrad Med 2014; 60: 113-5.
      10. Gogtay NJ, Thatte UM, Thaker SJ & Deshpande S. Need for and use of guidelines for reporting qualitative research. (letter to editor on paper by Mishra N et al). Ind Jr Med Res 2014; accepted for publication
      11. Thaker SJ, Gogtay NJ, Thatte UM. Pharmacoepidemiology: The essentials. Clinical Epidemiology and Global Health 2014; xxx 1-6
      12. Gogtay NJ, Nagpal A, Mallad A, Patel K, Stimpson SJ, Belur A, Thatte UM. Demographics of animal bite victims and management practices in a tertiary care institute in Mumbai, India. Indian J Med Res 2014; 139: 59-62.- Link to Study
      13. Patwardhan S, Gogtay NJ, Thatte U, Pramesh CS. A retrospective study comparing the quality and completeness of data documentation in an investigator initiated study versus an industry sponsored study. Indian J Med Ethics 2014; 11(1): 19-24.
      14. Gogtay NJ, Mali NB, Iyer K, Kadam PP, Sridharan K, Shrimal D, Thatte UM. Evaluation of cytochrome P450 2D6 phenotyping in healthy adult Western Indians. Ind. J. Pharmacol. 2014;46:266-9.
      15. Rajgor DD, Gogtay NJ, Kadam VS, Kocharekar MM, Parulekar MS, Dalvi SS, Vaidya AB, Kshirsagar NA. Anti relapse efficacy of various primaquine regimens for Plasmodium vivax. Malaria Red and Treatment 2014; 2014; doi. 10.1155/2014/347018/
      16. N.J. Gogtay, U.M. Thatte, S. Thaker & S. Deshpande Need for & use of guidelines for reporting qualitative research Indian J Med Res 140, December 2014, pp 788-789

YEAR-2013

      1. “Evaluation of factors that motivate participants to consent for non-therapeutic trials in India
        Maulik S Doshi, Shaunak P Kulkarni, Canna J Ghia, Nithya J Gogtay, Urmila M Thatte
        J Med Ethics Published Online First: 8 March 2013 doi:10.1136/medethics-2012-100755”
      2. Kalekar SA, Munshi RP, Bhalerao SS, Thatte UM. Insulin sensitizing effect of 3 Indian medicinal plants: An in vitro study. Indian J Pharmacol 45:30-3
      3. Gogtay NJ, Thatte UM, DasGupta B, Deshpande S Use of the WOMAC™ questionnaire in Mumbai and the challenges of translation and cross cultural adaptation, IJME, X (1): 33-35.
      4. Taur Santosh, Kulkarni Namrata, Gogtay Nithya, Thatte Urmila. An audit of therapeutic drug monitoring services of anticonvulsants at a tertiary care hospital in India, Therapeutic Drug Monitoring, Publ ahead of print 12 February 2013 doi: 10.1097/FTD.0b013e3182803d16
      5. Kannan S, Deshpande SP, Gogtay NJ & Thatte UM. Policy of reviewing statistics in Indian medical and surgical journals. Jr Pharmacol & Pharmacother 2013; 4: 139-40. DOI:10.4103/0976-500X.110897
      6. Kulkarni SP, Shah SR, Kadam PP, Kannan S, Hase NK, Shetty PP, Thatte UM & Gogtay NJ. Pharmacokinetics of a single dose (15 mg) Primaquine in patients with chronic kidney disease. Ind Jr Pharmacol 2013; (accepted, in press)
      7.  Nithya Gogtay, Sridharan Kannan, Urmila M Thatte, Piero L Olliaro, David Sinclair. Artemisinin-based combination therapy for treating uncomplicated Plasmodium vivax malaria. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD008492. DOI: 10.1002/14651858.CD008492.pub3″
      8. Kalekar A Samidha, Munshi P Renuka, Thatte M Urmila. Do plants mediate their anti-diabetic effects through anti-oxidant and anti-apoptotic actions? an in vitro assay of 3 Indian medicinal plants. BMC Complementary and Alternative Medicine.2013, 13:257. DOI: 10.1186/10.1186/1472-6882-13-257
      9. ND Karnik, K Sridharan, SP Jadhav, PP Kadam, RK Naidu, RD Namjoshi, V Gupta, MS Gore, PV Surase, PR Mehta, JA Gogtay, UM Thatte, NJ Gogtay. Pharmacokinetics of colistin in critically ill patients with multidrug-resistant Gram-negative bacilli infection. European Journal of Clinical Pharmacology DOI 10.1007/s00228-013-1493-9. (2013) 69:1429–1436
      10. MS Doshi, SP Kulkarni, Canna Ghia, NJ Gogtay, UM Thatte Evaluation of factors that motivate participants to consent for non-therapeutic trials in India. J Med Ethics 39(6):391-6
      11. Kulkarni SP, Shah SR, Kadam PP, Kannan S, Hase NK, Shetty PP, Thatte UM, Gogtay NJ. Pharmacokinetics of a single dose (15 mg) Primaquine in patients with chronic kidney disease. Indian J of Pharmacol, 45(4): 330-333.
      12. Bhalerao MS, Bolshete P, Swar BD, Bangera TA, Kolhe V, Tambe MJ, Wade M, Bowate S, Sonje U, Gogtay NJ, Thatte UM. A cross-sectional study to measure extent of use and Assess the Patients satisfaction with complementary and alternative Medicine (CAM) in four chronic diseases in a tertiary referral centre in India. NMJI, 26(2):75-78
      13. Doshi MS, Naik AA, Mehta MR, Gogaty NJ, Thatte UM, Menon M.Three-way, three-period, crossover bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers. Journal of Pharmacology and Pharmacothrerapeutics https://www.jppfirst.com/three-way-three-period-crossover-bioequivalence-study-single-oral-dose-three-brands-300-mg-phenytoin

YEAR-2012

      1. Shetty Y, Marathe P, Kamat S and Thatte U. Site monitoring by an IEC IJME, 2012;IX:22-6.
      2. Srivastava Rajneesh, Ray Sandipan, Vaibhav Vineet, Gollapalli Kishore, Jhaveri Tulip, Taur Santosh, Dhali Snigdha, Gogtay Nithya, Thatte Urmila, Srikanth Rapole, Srivastava Sanjeeva, Serum profiling of leptospirosis patients to investigate proteomic alterations, Journal of Proteomics (2012), doi: 10.1016/j.jprot.2012.04.007
      3. Ray S, Kamath KS, Srivastava R, Raghu D, Gollapalli K, Jain R, Gupta SV, Ray S, Taur S, Gogtay NJ, Thatte UM, Rapole S, Patankar S, Srivastava S. Serum proteome analysis of vivax malaria: An insight into the disease pathogenesis and host immune response Journal of Proteomics [https://dx.doi.org/10.1016/j.jprot.2011.10.018], 75:3063-80
      4. Thatte UM, Gogtay NJ, Kannan S, Oak S Title: Access to medicines for orphan diseases- experiences in the management of a case of Fasciola Hepatica in Mumbai, India. NMJI; VOL. 25, NO. 4, 234-35
      5. Sandipan Ray; Durairaj Renu; Rajneesh Srivastava; Kishore Gollapalli; Santosh Taur; Tulip Jhaveri; Snigdha Dhali; Srinivasarao Chennareddy; Ankit Potla; Jyoti Bajpai Dikshit; Rapole Srikanth; Nithya Gogtay; Urmila Thatte; Swati Patankar; Sanjeeva Srivastava, Serum Proteome Analysis of Falciparum and Vivax Malaria to Decipher Host Immune Response, Disease Pathogenesis, and Identify Surrogate Protein Markers”. PLOS One, 7 (8) e41751doi 10.1371journal.pone.0041751
      6. Gogtay NJ, Thatte UM, Kshirsagar NA, Leav B, Molrine D, Martin V, Wiggin H, Cheslock P, Sharma H, Barde P, Mangrule S, Kapre SV, Kulkarni PS. Safety and Pharmacokinetics of a Human Monoclonal Antibody to Rabies Virus: A Randomized, Dose-Escalation Phase I Study in Adults, Vaccine , 30: 7315-20
      7. Thakkar AN, Bendkhale SR, Taur SR, Gogtay NJ, Thatte UM. Association of CYP2C9 polymorphisms with phenytoin toxicity in Indian patients. Neurol India 2012; 60(6):577-580
      8. Supriya Bhalerao, Tejashree Deshpande, Urmila Thatte. Prakriti (Ayurvedic concept of constitution) and variations in platelet aggregation. BMC Complementary and Alternative Medicine 2012, 12:248 doi:10.1186/1472-6882-12-248

Read More

Protocols of Systematic Reviews

      1. A systematic review of the use of deception as an intervention in clinical research. read more
      2. The Zagreb versus Essen regime for post exposure prophylaxis of rabies” a systematic review and meta analysis. read more

Wards

      1. Clinical Pharmacology Ward in KEM Hospital (10 Beds)
      2. Clinical Pharmacology Ward for infectious diseases in Kasturba Hospital (25 Beds)
      3. CDRI Ward (10 Beds)

AREAS OF SPECIAL INTEREST AND WORK

      • Tropical diseases
      • Adverse Drug Reactions Monitoring
      • Therapeutic Drug Monitoring
      • Drug Delivery systems
      • Liposomal drug delivery
      • Pharmacogenetics

Trainees and Observers

2011

Amanda Burrage and Mathew Tyler, Undergraduate students from the University of Massachusetts, Boston, USA as part of a collaborative program with Mass Biologics, Boston, Jan- March 2011

2010

Sarah Jo Stimpson and Krunal Patel, April 2010. Undergraduate students from the University of Massachusetts, Boston, USA as part of a collaborative program with Mass Biologics, Boston

Location

First Floor
Multi storeyed building
Seth GS Medical College & KEM Hospital
Mumbai 400012

Contact Details

Executive assistant –
Mrs Ujwala Parulekar
Tel:91 22 24133767/24174420

Teaching Program

Journal club 
Presenter: Dr Pranav Gawande
Date: 7th July 2022 (Thursday)
Time: 03:00 pm onwards

For Student

For Patient

Levetiracetam blood levels available
Lamotrigine blood levels available
CYP2C9 genotyping for warfarin toxicity available

Photo Gallery

Phase I Unit Dept of Clinical Pharmacology
Workshop on “Principles of Scientific Writing” 12, 13 October 2017, conducted for Pfizer Ltd

Phase I Unit Dept of Clinical Pharmacology
Mr Ashnik Chauhan at the DIA meeting in Chicago in June 2017

Phase I Unit Dept of Clinical Pharmacology
Phase I Unit Dept of Clinical Pharmacology


90 years of Seth GS Medical College and KEM Hospital, January 2016
90 years of Seth GS Medical College and KEM Hospital, January 2016


Director General ICMR Dr Soumya Swaminathan’s visit to the Phase I unit, 10th Feb 2017

 


Dr Mahanjit Konwar was awarded the Dr. K. G Nair award’ as the First prize for Clinical Poster presentation at SAC-ACCP 2018 conference, Mumbai.


Dr Tushar Nishandar was awarded the Dr. A.S. Nanivadekar award’ as Second prize for Clinical Poster presentation at SAC-ACCP 2018 conference, Mumbai.
Topic: Current scenario of standardised,quality and ethical oversight of Clinical research in the country – an audit of the CDSCO (registration of ECs) and
NABH (accreditation) databases

Canvas of Clinical Pharmacology Workshop 2019