Prequalification: Training material

WHO/FIP Training Workshop on Dissolution, Pharmaceutical Product Interchangeability and
       Biopharmaceuticals Classification System (BCS)

       Kiev, Ukraine,  25 - 27 June 2007 

       Agenda (English Version)  [pdf]
       Agenda (Russian Version) [pdf]

      List of Participants:

      English Version  [pdf]
      Russian Version [pdf]

Presentations:

Monday, 25 June 2007

• Introduction [ppt]

• Guidelines on registration requirements to establish interchangeability [ppt]

• Options for establishing bioequivalence according to the new Guidance - (Russian Version) [ppt]

• Pharmacokinetic (PK) study design for establishing bioequivalence - (Russian Version) [ppt]

• Choice of comparator product for establishing bioequivalence - (Russian Version) [ppt]

• Interchangeability of multisource drug products containing highly variable drugs - (Russian Version) [ppt]

• Evaluation of bioequivalence (in vivo pharmacokinetic) studies - (Russian Version) [ppt]

Tuesday, 26 June 2007

• Why do dissolution testing? - (Russian Version) [ppt]

• Dissolution testing requirements for the biowaiver - (Russian Version) [ppt]

• Profile Comparison, BCS based biowaivers - (Russian Version) [ppt]

• Classification of the Essential Medicines List (EML) according to BCS - (Russian Version) [ppt]

• BCS - based biowaiver monographs - (Russian Version) [ppt]