WHO Bioequivalence Documents

Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability, Annex 7, World Health Organization, WHO Technical Report Series, No. 937, 2006.

Annex 8, Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms, World Health Organization, WHO Technical Report Series, No. 937, 2006.

Annex 8, Table 1, Substances on the WHO Model List of Essential Medicines (EML).

Annex 8, Table 2, Active pharmaceutical ingredients on the complementary list of the WHO Model List of Essential Medicines (EML)

Compounds introduced to the WHO Model List of Essential Medicines since March 2005 for which no certain classification had been previously reported (these compounds also appear in Table 1 and Table 2), Annex Table 3.

Additional guidance for organizations performing in vivo bioequivalence studies, World Health Organization, WHO Technical Report Series, No. 937, 2006, Annex 9.

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