BEBAC  Ing. Helmut Schütz

Fortieth Report (WHO Technical Report Series No. 937)

WHO Expert Committee on Specifications for Pharmaceutical Preparations

On 19 May 2006 the 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: