BIOAVAILABILITY AND BIOEQUIVALENCE

The IPAC-RS comments on FDA's Draft BA/BE Guidances are posted along with other comments at the bottom of the main page. In addition, the ITFG/IPAC-RS Collaboration has submitted three technical papers in response to the Agency’s draft guidance on bioavailability and bioequivalence (BA/BE):

1. On The Risks Of Eliminating In Vivo Studies For Nasal Solutions For Local Action

   In this document, the Collaboration encourages use of a risk management approach to regulatory decision making, especially in areas characterized by scarcity of relevant scientific evidence.

2. Review of the In Vivo and In Vitro Tests in FDA's Draft Guidance on Bioavailability and bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action and Anticipated Forthcoming Guidance for Orally Inhaled Drugs

   This document examines, through literature review, the Collaboration’s position statements that:

   i) in vitro testing is essential for pharmaceutical product equivalence and should be included as part of BA/BE Guidance for all nasal and oral inhalation products, but is not currently sufficient for BE approval without establishing in vivo BE; and

   ii) for BE approval, BA/BE Guidance documents for nasal and oral inhalation drug products for local action should require use of validated human models for in vivo testing for local and systemic exposure, efficacy and safety

3. Technical Paper on FDA's Bioavailability and Bioequivalence Questions Presented at 26 April 2000 OINDP Advisory Subcommittee Meeting

   This document contains the Collaboration’s responses to those questions regarding the BA/BE draft Guidance raised by the Agency during the 26 April 2000 OINDP Advisory Subcommittee meeting.