Good statistics practice in the drug development and regulatory approval process

During the development and approval process of a new drug, the concept of good statistics practice (GSP) is necessarily implemented. GSP is a set of principles which assures the validity of the design and analysis of the intended studies conducted at various stages of the process of drug development and regulatory approval. GSP provides a fair assessment of the drug product with the desired accuracy, precision, and reliability. In essence, GSP not only concerns the validity of statistical inference regarding drug efficacy and safety, but also provides assurance of the proper identity, strength, quality, purity, and stability of the drug product. This paper describes regulatory requirements for statistics and the role of statistics in the drug development and regulatory process. The concept and importance of GSP are illustrated through some practical and/or regulatory statistical issues that commonly occur during the drug development and regulatory approval process. © 1997, Drug Information Association. All rights reserved.

Duke Scholars

Author Shein-Chung Chow Biostatistics & Bioinformatics, Division of Biostatistics