Abstract:

Generic pharmaceutical products need to comply the same standards of quality, efficacy and safety as required of the innovator product. Generic drug market is expected to rise in coming future. Specifically, the Generic product should be therapeutically equivalent and interchangeable with the reference product. Present study highlights the regulatory guidelines for conduct of bioequivalence in India and the Gulf Cooperation Council States.

There is no international harmonization of regulatory requirements for bioequivalence, however, bioequivalence range and statistical analysis are to some extent harmonized, but there are differences in selection of subjects, food effect, application of multiple dose study, in vitro dissolution study, reference product etc.

In bioequivalence studies, the plasma concentration time curve is generally to assess the rate and extent of absorption. Selected pharmacokinetic parameters and preset acceptance limits allow the final decision on bioequivalence of the tested products. (AUC) the area under the concentration time curve reflects the extent of exposure. (C max) the maximum plasma concentration or peak exposure, and the time to maximum plasma concentration, (t max) are parameters that are influenced by absorption rate.

Bioequivalence study is one of the main requirements for generic drug approval process. This review provides an easy and quick overview for regulatory consideration required for bioequivalence study in those regions. In this paper includes information about important aspects of bioequivalence study design and specifications guidelines of each parameters also have been addressed.

Keywords: Bioequivalence, Bioavailability, Pharmacokinetics, GCC (Gulf Cooperation Council).

References:

[1].     Bioavailability / Bioequivalence: Current Draft Mar 2005 Requirements and Guidelines for Permission to Import and / or Manufacture of New Drugs for Sale or to Undertake Clinical Trials.

[2].     BA and BE - Central Drugs Standard Control Organization http://www.cdsco.nic.in/forms/list.aspx?lid=1855&Id=1.

[3].     CDSCO Guidelines for BA and BE studies http://www.pharmainfo.net/cdsco-guidelines-ba-and-be-studies.

[4].     Ethical Guidelines for Biomedical Research on Human Participants (published by the Indian Council of Medical Research): Oct 2006.

[5].     Guidelines for bioavailability & bioequivalence studies – CDSCO http://www.cdsco.nic.in/html/be%20guidelines%20draft%20ver10%20march%2016,%.pdf.

[6].     GCC Guidelines for Bioequivalence Retrieved from The https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/GCC_Guidelines_Bioequivalence.pdf.

[7].     Nitika K et al (2016) Study of Regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution. J Applied Pharmaceutical Science 6 (04 206-222. Doi: 10.7324/japs.2016.60430.

[8].     Pre-Screening revised checklist for BA/BE NOC for Export http://www.cdsco.nic.in/writereaddata/BABE_Prescreening%20checklist%202014.pdf.

[9].     Rani S, et al (2004) Bioequivalence: An overview of statistical concepts. Indian J Pharmacology 36: 209-216.

[10]. Revised checklist for BA/BE NOC effective from 01st February 2014 http://www.cdsco.nic.in/writereaddata/BABE%20website%202014%20revised%20document%2 0required.pdf.

[11]. Srivastav AK et al (2013) A Review Article on Bioavailability and Bioequivalence Studies. Intl J PharmTech Research4 (4) 1711-1721.

[12]. Schedule Y – Amended Version, Jun 2005 GCP: 2005 Submission of Clinical Trial Application for Evaluating Safety and Efficacy: v1.1 Dec 2008.

[13]. Tamboli AM et al (2010) An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products. J Bioequiv Availab 2:086-092. doi: 10.4172/jbb.1000037.

[14]. Upendra CG et al (2014) Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada. Saudi Pharmaceutical J 22, 391-402.