Wieschowski S

ORCID: 0000-0003-0128-2938 · 1 paper in corpus

2018

Preclinical efficacy in therapeutic area guidelines from the U.S. Food and Drug Administration and the European Medicines Agency: a cross-sectional study.

British journal of pharmacology ·doi:10.1111/bph.14485

Background and purposeTherapeutic area guidelines (TAGs) published by the EMA and the FDA offer guidance in planning the launch of a trial in a certain indication. We assessed and compared the guidance on preclinical efficacy of all availab…