Learning objectives
To provide the goals and the in vitro and in vivo methods for the preclinical studies of biotechnological drugs.
Course unit content
Legal aspects regulating the preclinical studies on biotechnological drugs
Studies assessing the quality of drugs
Studies assessing the biological activity of drugs
Studies assessing pharmacodynamics of drugs
Studies assessing pharmacokinetics of drugs
Bibliography
Walsh G, Biopharmaceutical: Biochemistry and Biotenchology, Wiley (1998)
Crommelin DJA, Sindelar RD, Pharmaceutical Biotechnology, Harwood Academic Publishers (1997)