Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

Labcompliance News, May 2001

May 08, 2001

New publication on Part 11: Biometrics-Based Authentication - Limitations and Possibilities

W.Winter and L.Huber, published in Biopharm,
In the sixth installment of the series, we define the role of biometrics for access and data security in the context of 21 CFR Part 11 ("the rule"). We discuss the differences between "traditional" and biometrics-based authentication schemes and where they may be required according to the rule. We conclude with practical recommendations for planning the deployment of biometrics-based authentication in the analytical laboratory. Download draft version from LabCompliance User Club

April 08, 2001

New FDA Guidance: Statistical Approaches to Establishing Bioequivalence

This new guidance provides recommendations to sponsors and applicants who intend, either before or after approval, to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and supplements to these applications. This guidance discusses three approaches for BE comparisons: average, population, and individual. The guidance focuses on how to use each approach once a specific approach has been chosen. This guidance replaces a prior FDA guidance entitled Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design, which was issued in July 1992..