Knowledge-based: facilitating access to medicines in Latin America
Talita da Silva Ferreira,
Giovanni M Pauletti,
Eduardo Agostinho Freitas Fernandes
et al.
Abstract:The World Health Organization (WHO), with the scientific support of the International Pharmaceutical Federation (FIP), guides the development of multisource pharmaceutical products for market authorization using in vivo bioequivalence studies or, where applicable, in vitro biowaiver strategies based on the Biopharmaceutical Classification System (BCS). A review of the regulatory framework guiding generic medicines approval in Latin American countries revealed that less than 50% of regional health authorities … Show more
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