(1999; 168 pages) [Spanish]
7.3 Multisource pharmaceutical products
The Committee noted with satisfaction the progress that had been made in developing a system for the selection of comparator products in support of the guidance on registration requirements to establish interchangeability for multisource (generic) pharmaceutical products, published in the report of the thirty-fourth meeting (14). The Secretariat was encouraged to pursue this initiative, in particular concerning international comparator products, taking account of a variety of approaches under current scientific and regulatory discussion. The development of a biopharmaceutical classification system using solubility, dissolution and permeability factors might provide a useful tool to determine when in vivo studies were needed or not (see also section 2.1).