This chapter provides an overview of studies typically conducted in nonclinical drug development programs. Many of these studies are conducted under regulatory governance, and reports of them are included in regulatory submissions requesting marketing approval. Three areas of investigation are considered here: pharmacokinetics, pharmacology, and toxicology. The scientific rationale of the studies is addressed, along with a summary of appropriate regulatory guidance.
KeywordsToxicology Study Cardiac Muscle Cell Interval Prolongation hERG Channel Drug Compound
- Cavagnaro, JA (Ed), 2008, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials. Hoboken, NJ: Wiley.Google Scholar
- Gad SC (Ed), 2008, Preclinical Development Handbook. Hoboken, NJ: Wiley.Google Scholar
- Rogge MC, Taft DR (Eds), 2009, Preclinical Drug Development, 2nd Edition. Totowa, NJ: Informa Healthcare.Google Scholar
- World Health Organization, 2010, Handbook of Good Laboratory Practice (GLP): Quality Practices for Regulated Non-clinical Research and Development. Geneva.Google Scholar