This preview shows page 1. Sign up to view the full content.
Unformatted text preview: concepts and methodologies are illustrated through real-world examples whenever possible. Clinical research is a lengthy and costly process that involves drug discovery, formulation, laboratory development, animal studies, clinical development, and regulatory submission. This lengthy process is necessary not only for understanding the target disease but also for providing sub-stantial evidence regarding ecacy and safety of the pharmaceutical com-pound under investigation prior to regulatory approval. In addition, it provides assurance that the drug products under investigation will possess good characteristics such as identity, strength, quality, purity, and stability after regulatory approval. For this purpose, biostatistics plays an impor-Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved....
View Full Document
- Spring '11