Author(s):
Sharad Desai, Nilesh Patel
Email(s):
sharadarva@gmail.com , nileshcology127@gmail.com
DOI:
10.52711/2321-5836.2021.00026 
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:
Nowadays health agencies of regulated markets are becoming stringent regarding the bio-studies. So clinical/contract research organization (CRO) need to be selected carefully after their detailed assessment. As per requirement of bio-study CRO should be assessed with the study specific checklist of questions before awarding the bio-study. Questions related to various services of study like: Clinic phase, analytical phase, Pharmacokinetic and statistical phase, ethics approval, QA/QC, record handing etc. and related to CRO capabilities are discussed here with their relevance to conclude the abilities of CRO for successful execution of bio-study. Hence, this paper focuses all possible questions which need to be assessed before selection of CRO mainly for Bioavailability/Bioequivalence (BABE) study in healthy adult volunteers. Properly selected CRO will help for smooth execution of study and quality report and subsequently, hassle-free approval of dossier submitted to regulatory agency.
Cite this article:
Sharad Desai, Nilesh Patel. Checklist to select contract Research Organization for early phase Bioavailability/Bioequivalence Clinical Studies in Healthy Adult Human Volunteers. Research Journal of Pharmacology and Pharmacodynamics. 2021;13(4):131-2. doi: 10.52711/2321-5836.2021.00026
Cite(Electronic):
Sharad Desai, Nilesh Patel. Checklist to select contract Research Organization for early phase Bioavailability/Bioequivalence Clinical Studies in Healthy Adult Human Volunteers. Research Journal of Pharmacology and Pharmacodynamics. 2021;13(4):131-2. doi: 10.52711/2321-5836.2021.00026 Available on: https://rjppd.org/AbstractView.aspx?PID=2021-13-4-5
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