1. Directive 2001/20/EC Article 2(d) of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Eur-Lex;European Commission;OJEC.,2001
2. Dose-finding studies in clinical drug development;Schmidt;Eur J Clin Pharmacol.,1988
3. Committee for medicinal products for human use (CHMP) ICH guideline S6(R1)-preclinical safety evaluation of biotechnology-derived pharmaceuticals