Fortieth Report (WHO Technical Report Series No. 937)
WHO Expert Committee on Specifications for Pharmaceutical Preparations
On 19 May 2006 WHO’s Fortieth Report was published.
Annexes 7-9 provide an excellent overview of the current recommendations (on in vivo BE studies, biowaivers based on dissolution testing and technical/organisational requirements for CROs), namely:
- Annex 7
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (425kB PDF)
- Annex 8
Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (464kB PDF)
- Annex 9
Additional guidance for organizations performing in vivo bioequivalence studies (371kB PDF)
