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KING EDWARD MEMORIAL HOSPITAL
SETH GORDHANDAS SUNDERDAS MEDICAL COLLEGE

बृहन्मुंबई महानगरपालिका रुग्णालय

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Clinical Pharmacology

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

DM Clinical Pharmacology renewal of recognition upto April 2028 by National Medical Commission [NMC]

Courses Offered – 2023

  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
  1. MSc- Applied Biology – Mumbai University
  2. Two week hands training course in Therapeutic Drug Monitoring
  3. One week hands on training course in Adverse Drug Reactions Monitoring
  4. 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

  1. 40 bedded ward (of this 26 beds at the Kasturba Hospital for infectious diseases)
  2. PhD Clinical Pharmacology- Maharashtra University of Health Sciences
  3. 3 bedded state of the art Phase 1 unit
  4. Therapeutic Drug Monitoring lab and patient care services
  5. Pharmacogenetics lab and patient care services

Standard Operating Procedures [SOPs]

Sr. No 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

For Student

Awards & Honors

  • Dr Ananya Rakshit (First year DM resident) presented an oral paper on ‘Status of registration and re-registration of Ethics Committee in CDSCO and DHR – evaluation of extent of Ethical oversight in the country’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Dr Dhruve Soni (Final year DM resident) presented an oral paper on ‘Evaluation of the risk of allergy to COVID-19 vaccines in people with a history of allergic diathesis’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Dr Sukant Pandit (First year DM resident) presented an oral paper on ‘Comparison of WHO-UMC and Naranjo scales for causality assessment of reported adverse drug reactions’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Second prize for oral presentation: Dr Bhaskar Krishnamurthy (Assistant Professor) has won the 2nd prize in the oral presentation category for the paper ‘Economic analysis of renal transplant services in a tertiary care hospital’ at the 14th Annual Conference of the ‘Indian Society for Rational Pharmacotherapeutics’ (ISRPTcon) in Hyderabad from (10th – 12th of November 2022).
  • Dr Jeffrey Pradeep Raj (Assistant Professor) presented an oral paper on ‘Can a Discrete Choice Experiment (DCE) help understand COVID-19 vaccine Hesitancy? A study from India’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).
  • Dr Palvi Kudyar (Assistant Professor) presented an oral paper on ‘Evaluation of satisfaction and reasons for participation in a COVID-19 Vaccine Clinical Trial: a single centre observational study’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).
  • Dr Dhruve Soni (Final year DM resident) presented an oral paper on ‘Assessment of factors that motivate participants to take part in a COVID-19 vaccine study’ at the  22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).

  • Dr Ananya Rakshit (First year DM resident) presented an oral paper on ‘Status of registration and re-registration of Ethics Committee in CDSCO and DHR – evaluation of extent of Ethical oversight in the country’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Dr Dhruve Soni (Final year DM resident) presented an oral paper on ‘Evaluation of the risk of allergy to COVID-19 vaccines in people with a history of allergic diathesis’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Dr Sukant Pandit (First year DM resident) presented an oral paper on ‘Comparison of WHO-UMC and Naranjo scales for causality assessment of reported adverse drug reactions’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Second prize for oral presentation: Dr Bhaskar Krishnamurthy (Assistant Professor) has won the 2nd prize in the oral presentation category for the paper ‘Economic analysis of renal transplant services in a tertiary care hospital’ at the 14th Annual Conference of the ‘Indian Society for Rational Pharmacotherapeutics’ (ISRPTcon) in Hyderabad from (10th – 12th of November 2022).
  • Dr Jeffrey Pradeep Raj (Assistant Professor) presented an oral paper on ‘Can a Discrete Choice Experiment (DCE) help understand COVID-19 vaccine Hesitancy? A study from India’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).
  • Dr Palvi Kudyar (Assistant Professor) presented an oral paper on ‘Evaluation of satisfaction and reasons for participation in a COVID-19 Vaccine Clinical Trial: a single centre observational study’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).
  • Dr Dhruve Soni (Final year DM resident) presented an oral paper on ‘Assessment of factors that motivate participants to take part in a COVID-19 vaccine study’ at the  22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).

  • Dr Ananya Rakshit (First year DM resident) presented an oral paper on ‘Status of registration and re-registration of Ethics Committee in CDSCO and DHR – evaluation of extent of Ethical oversight in the country’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Dr Dhruve Soni (Final year DM resident) presented an oral paper on ‘Evaluation of the risk of allergy to COVID-19 vaccines in people with a history of allergic diathesis’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Dr Sukant Pandit (First year DM resident) presented an oral paper on ‘Comparison of WHO-UMC and Naranjo scales for causality assessment of reported adverse drug reactions’ at the 1st Annual Conference of National Association of Pharmacology and Therapeutics (NAPTICON) at Mangalore, Karnataka (28th – 29th October 2022).
  • Second prize for oral presentation: Dr Bhaskar Krishnamurthy (Assistant Professor) has won the 2nd prize in the oral presentation category for the paper ‘Economic analysis of renal transplant services in a tertiary care hospital’ at the 14th Annual Conference of the ‘Indian Society for Rational Pharmacotherapeutics’ (ISRPTcon) in Hyderabad from (10th – 12th of November 2022).
  • Dr Jeffrey Pradeep Raj (Assistant Professor) presented an oral paper on ‘Can a Discrete Choice Experiment (DCE) help understand COVID-19 vaccine Hesitancy? A study from India’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).
  • Dr Palvi Kudyar (Assistant Professor) presented an oral paper on ‘Evaluation of satisfaction and reasons for participation in a COVID-19 Vaccine Clinical Trial: a single centre observational study’ at the 22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).
  • Dr Dhruve Soni (Final year DM resident) presented an oral paper on ‘Assessment of factors that motivate participants to take part in a COVID-19 vaccine study’ at the  22nd Annual FERCAP (Forum for Ethical Review Committees in the Asian and Western Pacific Region) Conference, 2022 at Daegu, South Korea (27th – 30th November 2022).

Other

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

  • Dr Nithya Gogtay – Professor and Head
  • Dr Mahesh Belhekar – Associate Professor
  • Dr Bhaskar Krishnamurthy- Assistant Professor
  • Dr Urmila Thatte – Emeritus Professor
  • Dr Tejashri Jaju- Senior Resident

  • Dr Vijaya Gunjal [Joining Date- 19.10.22]
  • Dr Palvi Kudyar [Joining Date- 19.10.22]

  • Dr. Sunita Chhapola Shukla – Consultant Allergologist
  • Dr Durga Gadgil – Consultant [Drug Development and Pharmaceutical Medicine]

    Final year residents

  • Dr Dhruve Soni
  • Dr Sukant Pandit
  • Dr Shakeeb Dhorajiwala

    Second year residents

  • Dr Ananya Rakshit
  • Dr Roopa Parida

    First year residents

  • Dr A Vinayak
  • Dr Rupali Mishra

  • Assistant Professor/Senior Medical Officer – Dr Jeffrey Pradeep Raj
  • Project Scientist – Dr Sheetal Kudtarkar
  • Project Associate – Ms Leena Sawant
  • Pharmacist – post vacant
  • Scientific Admin Assistants
  • Ms Vaishali Hadikar
  • Ms Priyanka Shivdas
  • Ms Saee Hinglaspurkar

  • Ms. Shital Bendkhale – Laboratory In Charge

  • Registrar- Post vacant

  • Dr Nithya Gogtay – Professor and Head
  • Dr Mahesh Belhekar – Associate Professor
  • Dr Bhaskar Krishnamurthy- Assistant Professor
  • Dr Urmila Thatte – Emeritus Professor
  • Dr Tejashri Jaju- Senior Resident

  • 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

  • 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

  • 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

  • Dr Mahesh Belhekar
  • Dr Shantanu Joshi
  • Dr Jeffrey Pradeep Raj

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 Taure 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)

View for the use of deception in clinical research

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

  • Kudyar P, Soni D, Gogtay NJ. Evaluation of satisfaction and reasons for participation in a Covid-19 vaccine clinical trial: A singlecentre, observational study. Natl Med J India 2022:35:214–18.
  • Kulkarni PS, Kadam A, Godbole S, Bhatt V, Raut A, Kohli S, Tripathi S, Kulkarni P, Ludam R, Prabhu M, Bavdekar A, Gogtay NJ et al. COVOVAX Study Group. Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study. Lancet Reg Health Southeast Asia 2023; doi: 10.1016/j.lansea.2022.100139. Epub 11 Jan 2023
  • Karande S, Gogtay NJ, Shaikh N, Sholapurwala R, More T, Meshram P. Self-perceived anxiety symptoms in school students with borderline intellectual functioning: A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India. J Postgrad Med. 2023; 69(2):89-96.
  • Karande S, Gogtay NJ, More T, Sholapurwala RF, Pandit S, Waghmare S. Economic burden of limited English proficiency: A prevalence-based cost of illness study of its direct, indirect, and intangible costs. J Postgrad Med. 2023; 69(1):27-34.
  • Chaudhari VL, Godbole CJ, Bendkhale SR, Desai NN, Gogtay NJ, Thatte UM. An audit of questions asked by participants during the informed consent process for a phase 2/3 COVID-19 vaccine regulatory study at a tertiary referral centre. J Postgrad Med 2023; 69(1):21-26
  • Raj JP, Maurya MR, Nair N, Marfatia H, Hadaye R, Gogtay NJ. Efficacy and safety 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. Complement Ther Med 2023; 73:102934.
  • Belhekar MN, Dhorajiwala SS, Krishnamurthy B. Impact of educational interventions on pharmacovigilance and adverse drug reaction reporting by resident doctors and faculty members: A prospective comparative study. Perspect Clin Res. 2023 Jan-Mar;14(1):32-38.

  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
  6. Nayak P, Pantvaidya G, Ranganathan P, Jinwani S, Joshi S, Gogtay NJ. Clinical Studies with Cannabis – evolving guideline on what Indian Investigators, and Ethics Committees should know. Accepted for publication in Perspectives in Clinical Research. 
  7. Belhekar MN, Dhorajiwala SS, Krishnamurthy B. Impact of educational interventions on pharmacovigilance and adverse drug reaction reporting by resident doctors and faculty members: A prospective comparative study. Perspect Clin Res. (Epub ahead of print)
  8. Kamble N, Mathur R, Gavali V, Prabhu S, Krishnamurthy B, Bodhanwala M. Sensory stimulation and play therapy: A tool to combat severe wasting in India? Emergency Nutrition Network (Epub ahead of print)
  9. Karande S, Gogtay NJ, More T, Pandit S, Praveenkumar. Parental‑perceived health‑related quality of life of school students with borderline intellectual functioning: A cross‑sectional questionnaire‑based study in Mumbai, Maharashtra, India. J Postgrad Med 2022;68:213-20
  10. Gogtay NJ. Medical research in India: fit and fine or frail and vulnerable? Nat Med Jr Ind 2022; 35(3): 129-131. [Editorial] 
  11. Belhekar MN, Joshi KK. Relationship of Hearing Impairment in Patients with Lamivudine Therapy: A Systematic Review and Meta-analysis. J Clin Diagn Res 2022; 16(12):1-5.Belhekar MN, Joshi KK. Relationship of Hearing Impairment in Patients with Lamivudine Therapy: A Systematic Review and Meta-analysis. J Clin Diagn Res 2022; 16(12):1-5.
  12. Belhekar MN, Dhorajiwala SS. A prospective comparative study to evaluate the impact of educational interventions on knowledge, attitude, and practice about pharmacovigilance among nurses. Natl J Physiol Pharm Pharmacol 2022;12(08):1164-1170.

  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.

  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.
  17. Joshi KK, Belhekar MN. Association of hearing loss in the patients treated with lamivudine: a systematic review protocol. Int J Clin Trials 2020;7(4):262-70.

  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.

  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.

    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.

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

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

Photo Gallery

Visit on 29 May 23 by Professor Joseph Muenzer, Pediatric Geneticist , University of North Carolina

Workshop on “Principles of Scientific Writing” 12, 13 October 2017, conducted for Pfizer Ltd

Mr Ashnik Chauhan at the DIA meeting in Chicago in June 2017

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