Author(s): Sharad Desai, Nilesh Patel

Email(s): nileshcology127@gmail.com

DOI: 10.52711/2321-5836.2021.00033   

Address: 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.
*Corresponding Author

Published In:   Volume - 13,      Issue - 4,     Year - 2021


ABSTRACT:
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

Cite(Electronic):
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


REFERENCES:
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

Recomonded Articles:

Author(s): Aswani P. S., Kshirod Kumar Ratha, Dighe Dattatray Pandurang, M. M. Rao, Remya Vijayan

DOI: 10.5958/2321-5836.2018.00008.3         Access: Open Access Read More

Author(s): Shameer Pasha, Mohamed Khaleel, Sukhen Som.

DOI: Not Available         Access: Open Access Read More

Author(s): Ajay Saxena, PK Rai, Ajay Meena, Anupam Srivastava, Kiran Srivastava, Priyanka Pandey.

DOI: Not Available         Access: Open Access Read More

Author(s): Srinibash Sahoo, BCS Rao, AK Das, Kamadev Das.

DOI: Not Available         Access: Open Access Read More

Author(s): Sudhanshu Kumar Meher, Purnendu Panda, Banmali Das, G. C. Bhuyan, Dr. K. K. Rath

DOI: 10.5958/2321-5836.2018.00023.X         Access: Open Access Read More

Author(s): Rohit J. Bhor, Harshala Damdhar, Geeta Kokate, Maduri Salve, Swati Andhale

DOI: 10.5958/2321-5836.2016.00025.2         Access: Open Access Read More

Author(s): Kimbi, RB Ambola, Nabila VS Ajong, Emmanuel N Tufon

DOI:         Access: Open Access Read More

Author(s): Ajay Saxena, Pravin Kumar Rai, Ajay Kumar Meena, Anupam Srivastava, Priyanka Pandey, Kiran Shrivastava, Shikha Sharma , Gyanendra Dutt Shukla.

DOI: Not Available         Access: Open Access Read More

Author(s): Upadhyay SU, Jain VC, Upadhyay UM.

DOI: 10.5958/2321-5836.2015.00021.X         Access: Open Access Read More

Author(s): Jhakeshwar Prasad, Ashish Kumar Netam, Mahendra Kumar Sahu, Trilochan Satapathy

DOI: 10.5958/2321-5836.2017.00027.1         Access: Open Access Read More

Author(s): Kuchake VG, Patil PH, Mahajan HS, Ingle PV, Surana SJ, Thakare MM, S Sudharshini.

DOI: Not Available         Access: Open Access Read More

Author(s): Parveen Ranga, Amita Sharma

DOI: 10.5958/2321-5836.2017.00032.5         Access: Open Access Read More

Author(s): Shruthi. K.V, Basavaraj Bandare, Satyanarayana. V, Sanjana Prakash

DOI: 10.5958/2321-5836.2017.00012.X         Access: Open Access Read More

Author(s): Rohit R. Patil, Mayur A. Chaudhari, Tushar A. Deshmukh

DOI: 10.5958/2321-5836.2018.00016.2         Access: Open Access Read More

Author(s): Anita S Wanjari, Namrata B. Chouragade.

DOI: 10.5958/2321-5836.2015.00022.1         Access: Open Access Read More

Author(s): Raghava Ramesh Narayana, KP Shivalinge Gowda, Syed Mansoor Ahamed and S Badami.

DOI: Not Available         Access: Open Access Read More

Author(s): Vadivelan R, Dhanabal SP, Patil Mohan, Shanish A, Elango K, Suresh B.

DOI: Not Available         Access: Open Access Read More

Author(s): Archana R Dhole, Vikas R Dhole, Chandrakant S Magdum, Shreenivas Mohite.

DOI: Not Available         Access: Open Access Read More

Research Journal of Pharmacology and Pharmacodynamics (RJPPD) is an international, peer-reviewed journal....... Read more >>>

RNI: Not Available                     
DOI: 10.5958 2321-5836 


Recent Articles




Tags