Sharad Desai, Nilesh Patel
Sharad Desai1, Nilesh Patel2*
1Ph.D Research Scholar, Ganpat University, Ganpat Vidyanagar-384012, Mehsana, Gujarat, India.
2Associate Professor and Head, Department of Pharmacology, Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar-384012, Mehsana, Gujarat, India.
Volume - 13,
Issue - 4,
Year - 2021
This paper presents the results of Demographic and Participation Details of Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. For that data of 50 participants was collected using self-administered questionnaire. After ethics approval, data were collected between between Jul-21 and Aug-21 from Gujarat state of India. Results of demographic and participation details are tabulated by its frequency and percentage. Participants are participating more whose age range were 18-41 years, income less than one lakh, education below Higher Secondary and having private job or wage-earner. Age of first time participation was found in range of 18-41 years and frequency of number studies in which participant participated were found from 01 to 20 studies. Also Chi-Square results suggested there is significant (p < 0.05) relation (I) between the Education and Age of first time participation (II) between the occupation and number of times participated.
Cite this article:
Sharad Desai, Nilesh Patel. Demographic and Participation Details of Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. Research Journal of Pharmacology and Pharmacodynamics. 2021;13(4):105-110. doi: 10.52711/2321-5836.2021.00033
Sharad Desai, Nilesh Patel. Demographic and Participation Details of Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. Research Journal of Pharmacology and Pharmacodynamics. 2021;13(4):105-110. doi: 10.52711/2321-5836.2021.00033 Available on: https://rjppd.org/AbstractView.aspx?PID=2021-13-4-1
1. Srinivasan S. Ethical concerns in clinical trials in India: An investigation. Centre for studies in Ethics and Rights (CSER) [Last accessed on 2021 Oct]. Available from: https://www.researchgate.net/publication/265071503_Ethical_concerns_in_clinical_trials_in_India_an_investigation
2. Indian Pharmaceutical Industry 2021: future is now. February 2021. Ernst and Young LLP, Kolkata. [Last accessed on 2021 Oct]. Available from: https://assets.ey.com/content/dam/ey-sites/ey-com/en_in/topics/health/2021/ey-ficci-indian-pharma-report-2021.pdf?download
3. Thatte, U.M. Bavdekar, S.B. Clinical research in India: Great expectations? J. Postgrad. Med. 2008; 54: 318–323.
4. Yogendra K. Gupta. Biswa M. Padhy. India's growing participation in global clinical trials. Trends Pharmacol Sci. 2011; 32(6): 327–329. doi:10.1016/j.tips.2011.02.017
5. Madsen SM. Mirza MR. Holm S. Hilsted KL. Kampmann K. Riis P. Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med. 2002; 251(2): 156–168. doi:10.1046/j.1365- 2796.2002.00949.x
6. Agrawal M. Grady C. Fairclough DL. Meropol NJ. Maynard K. Emanuel EJ. Patients’ decision-making process regarding participation in phase I oncology research. J Clin Oncol. 2006; 24(27): 4479– 4484. doi:10.1200/JCO.2006.06.0269
7. Ranjan Rajesh. Agarwal Nidhi Bharal. Kapur Prem. Marwah Amit. Parveen Rizwana. Factors influencing participation of healthy volunteers in clinical trials: findings from a cross-sectional study in Delhi, North India. Patient Preference and Adherence. 2019; 13: 2007–2015. doi:10.2147/PPA.S206728
8. Vetchý D. Frýbortová K. Rabisková M. Daneckova H. Bioequivalence studies of pharmaceutical preparations. Cas Lek Cesk. 2007; 146(5): 431–433. PMID: 17554963
9. Upendra C Galgatte Vijay R Jamdade. Pravin P Aute1. Pravin D Chaudhari. Study on requirements of bioequivalence for registration of pharmaceutical products in India, South-Africa and Australia. Am J Pharm Tech Res. 2013; 3(1): 289–305.
10. Emanuel EJ. Wendler D. Killen J. Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004;189 (5): 930–937. https://doi.org/10.1086/381709