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


REFERENCES:
1.    Dennis Salotti. Industry Report on Outsourcing Spend, Models, and Measures. Applied Clinical Trials. 2019; 28: 10-16.
2.    R. K. Verma. Generic Medicines: Core Issues and Legal Mechanism. International Journal of Reviews and Research in Social Sciences. 2019; 7 (2): 405-414. doi: 10.5958/2454-2687.2019.00033.9
3.    Michael Hennig, Ferdinand Hundt, Susanne Busta, Stefan Mikus, Per-Holger Sanden, Andrea Sörgel et al. Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa). GMS German Medical Science. 2017; 15: 1-15. doi: 10.3205/000243
4.    Lovely Joylen Castelino, Anoop Narayanan V, Swapnil Dylan Fernandes, Pankaj Kumar, Sandeep D S. Good Clinical Practices: An Indian Perspective. Research J. Pharm. and Tech. 2018; 11 (7): 3209-3215. doi: 10.5958/0974-360X.2018.00590.5
5.    Anonymous. E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1). Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration. 2018.
6.    Eric Langer. Survey Examines Trends in the Outsourcing Relationship. BioPharm International. 2011, [cited 2021 Apr 26]; 24 (10). Available on: http://www.biopharminternational.com/ survey-examines-trends-outsourcing-relationship
7.    2014 Annual Outsourcing Survey. Contract Pharma. 2014, [cited 2021 May 02]. Available on: https://www.contractpharma.com/ contents/view_outsourcing-survey/2014-05-11/2014-annual-outsourcing-survey/
8.    Patil SM, Sapkale GN, Kumbhar PB and Maske AP. Quality Assurance in Clinical Trial. Research J. Pharmacology and Pharmacodynamics. 2010; 2 (1): 01-04.
9.    Muniyandi S. Bio Ethics in Research. International Journal of Advances in Nursing Management. 2017; 5 (4): 351-353. doi: 10.5958/2454-2652.2017.00074.9
10.    Ragul Viknesh V, Saranya P. Pharmacovigilance - An Overview in a Pharmacist Perspective. Research J. Pharm. and Tech. 2020; 13 (8): 3941-3946. doi: 10.5958/0974-360X.2020.00697.6
11.    Shraddha Anil Naik. Review on Pharmacovigilance. Asian Journal of Pharmaceutical Research. 2020; 10 (2): 123-128. doi: 10.5958/2231-5691.2020.00024.6
12.    Manohar D. Kengar, Kiran K. Patole, Akshay K. Ade, Sumesh M. Kumbhar, Chetan D. Patil, Ashutosh R. Ganjave. Introduction to Pharmacovigilance and Monitoring. Asian Journal of Pharmaceutical Research. 2019; 9 (2): 116-122. doi: 10.5958/2231-5691.2019.00019.4
13.    Thakur Abhimanyu, Kondru Sushmita, Kamilya Shruti, Kumar Amit, Goldar Epshita. Assessment of Prevailing Insurance Policies and Regulations in Context of Clinical Research Industry. Asian J. Pharm. Res. 2015; 5 (2): 114-117. doi: 10.5958/2231-5691.2015.00017.9
14.    Anonymous. Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application. Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration. 2008.
15.    Swati Saxena, Sarang Jain. A Review on Biopharmaceutical Classification System. Asian Journal of Pharmacy and Technology. 2019; 9 (4): 267-270. doi: 10.5958/2231-5713.2019.00044.8
16.    SV Deshmane, PP Chinchole, RM Gaurkhede, MA Channawar and AV Chandewar. The Biopharmaceutics Classification System: A Review. Research J. Pharm. and Tech. 2009; 2 (1): 8-11. doi:
17.    Tilde Dombernowsky, Merete Haedersdal, Ulrik Lassen, Simon Francis Thomsen. Criteria for site selection in industry- sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations. Trials. 2019; 20: 2-12. doi:10.1186/s13063-019-3790-9
18.    Michael Strauss, Jeanne Novak. Selection and oversight of domestic and international CMOs. BioProcess International. 2009; 24-31.
19.    Harold E. Glass, Daniel P. Beaudry. Key factors in CRO selection. Applied Clinical Trials. 2008, [cited 2021 Jun 01]. Available on: http://www.appliedclinicaltrialsonline.com/key-factors-cro-selection-0

Recomonded Articles:

Author(s): Purnendu Panda, Banamali Das, DS Sahu, SK Meher, BK Das, MM Rao, GChD Naga Lakshmi.

DOI: 10.5958/2321-5836.2015.00011.7         Access: Open Access Read More

Author(s): Shilpa Maria, IJ Kuppast, JH Virupaksha, M Vanajakshi, K Prasad.

DOI: 10.5958/2321-5836.2015.00033.6         Access: Open Access Read More

Author(s): Sudhanshu Kumar Meher, Banmali Das, Purnendu Panda, GC Bhuyan, MM Rao.

DOI: 10.5958/2321-5836.2016.00006.9         Access: Open Access Read More

Author(s): T. Shekshavali, S. Roshan

DOI: 10.5958/2321-5836.2016.00031.8         Access: Open Access Read More

Author(s): K. Rashid, C. Senthil Kumar, P. M. Mohammed Haleel

DOI: 10.5958/2321-5836.2017.00037.4         Access: Open Access Read More

Author(s): Madhavi Sahu, S. Prakash Rao

DOI: 10.5958/2321-5836.2018.00031.9         Access: Open Access Read More

Author(s): Prathib B, Nikhil P Varghese, Virupaksha J. H, Kuppast I. J.

DOI: 10.5958/2321-5836.2017.00006.4         Access: Open Access Read More

Author(s): M Lavanya, Asish Bhaumik, A Gopi Reddy, Ch Manasa, B Kalyani, S Sushmitha

DOI: 10.5958/2321-5836.2016.00012.4         Access: Open Access Read More

Author(s): Sanjib Kumar Das, Anuradha Das, Banamali Das, Purnendu Panda, G. C. Bhuyan, Bipin Bihari Khuntia

DOI: 10.5958/2321-5836.2017.00036.2         Access: Open Access Read More

Author(s): Satish Narra, Bandenawaz Ramadurg, Saraswathi C D.

DOI: Not Available         Access: Open Access Read More

Author(s): Subbiah Murugesan, Sundaresan Bhuvaneswari, U.S. Mahadeva Rao, Vajiravelu Sivamurugan

DOI: 10.5958/2321-5836.2017.00022.2         Access: Open Access Read More

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

DOI:         Access: Open Access Read More

Author(s): Khushbu Chauhan, Payal Santwani, Lalkrushn Parmar, Roshni Solanki. Subodh Adeshara.

DOI: Not Available         Access: Open Access Read More

Author(s): Ajay Kumar Meena, Himanshu Sehgal, MM Rao, P Panda, MM Padhi.

DOI: Not Available         Access: Open Access Read More

Author(s): D. Benito Johnson, Faisal N.V, Rashid. K, Mohammed Haleel, V. Venkatanarayanan

DOI: 10.5958/2321-5836.2016.00018.5         Access: Open Access Read More

Author(s): Thakur Akash U., Popat Ritesh R., Mhaske Shivshankar D., Narkhede Mahesh B., Chinchole Pavan P., Shrikhande Vinayak N

DOI: 10.5958/2321-5836.2017.00019.2         Access: Open Access Read More

Author(s): Serene Adak, Dipesh Chakraborty, Himangshu S. Maji, Satakshi Basu, Pradip Roy, Sutanuka Mitra, Nabanita Mukherjee, Samarendra Barik, Arunava Goswami

DOI: 10.5958/2321-5836.2018.00009.5         Access: Open Access Read More

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

DOI: 10.5958/2321-5836.2018.00007.1         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

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