Potential influence of international harmonization of pharmaceutical regulations on biopharmaceutical development

In the late 1980s, two independent efforts occurred that focused on reducing parallel regulatory requirements in different countries. These requirements had led to the need for duplicative testing to address a single issue when a single well-designed study would have been adequate to meet a sensible...

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Veröffentlicht in:	Current opinion in biotechnology 1997-06, Vol.8 (3), p.350-356
1. Verfasser:	Lubiniecki, Anthony S
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Biopharmaceutics - legislation & jurisprudence Biotechnology - legislation & jurisprudence Cell Line Drug Industry Drug Stability Genetic Engineering - legislation & jurisprudence International Cooperation Legislation, Pharmacy Safety Viruses - pathogenicity
Online-Zugang:	Volltext
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