Basic Course on Human Pharmacology

AGAH has initiated a course schedule for basic human pharmacology education. The course is split into 2 parts, together giving insight into all relevant aspects of human pharmacology. Weiterlesen...

Global Bioequivalence Harmonisation Initiative (GBHI)

Since decades, bioequivalence is considered one of the key questions in new and generic drug product development and registration worldwide. At the same time, it is obvious that the regulations and jurisdictions still differ to certain extent from country to country and continent to continent, although the scientific basis for it is globally the same. This aspect, and the on-going discussion on the suitability of reference products purchased from a specific country and their applicability for submissions in other countries or regions, create the necessity to conduct several only slightly different bioequivalence studies to get the same product authorised in various markets. Weiterlesen...
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