RAPS San Francisco Chapter: Recent Bioequivalence Studies With CMC Implications for Pre- and Postapp

Product quality underpins safety and efficacy.  Contributors to on-going quality are CMC/formulation science and well-designed analytical/equivalence methods/standards. The goal of this presentation is to review three recently completed bioequivalence studies that outline the formulation impact on product performance. The average bioequivalence standard will be discussed in the context of patient sub-populations. Discussion will include how drug bioequivalence history may inform the developing biosimilarity standard. This lecture is designed for regulatory professionals with an interest in CMC and drug/biologics equivalence issues.

This event is sponsored by the RAPS San Francisco Bay Area Chapter and is intended to facilitate networking and knowledge sharing among area regulatory personnel. A light meal will be available for all attendees. RAC holders may claim three RAC recertification credits.