Good Statistics Practice in the Drug Development and Regulatory Approval Process
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0092-861397 Copyright 0 1997 Drug Information Association Inc.
GOOD STATISTICS PRACTICE IN THE DRUG DEVELOPMENT AND REGULATORY APPROVAL PROCESS SHEIN-CHUNG CHOW,PHD Executive Director, Biostatistics and Data Management, Covance, Inc., Princeton, New Jersey
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 ana7or regulatory statistical issues that commonly occur during the drug development and regulatory approval process. Key Words: Code of Federal Regulations; United States Pharmacopeia and National Formulary; Good laboratory practice; Good clinical practice; Current good manufacturing practice; Good research practice; Good statistics practice
INTRODUCTION
clinical evaluation due to the toxicity or intolerability in animals or humans. After a promTHE DEVELOPMENT OF a pharmaceutical ising compound is obtained, the clinical deentity is a lengthy process involving drug velopment and regulatory approval process discovery, formulation, laboratory developis also time consuming, which is necessary ment, toxicological studies, clinical developto assure the effectiveness and safety of the ment, and regulatory registration. The whole promising compound. process is not only time consuming but also For the development of pharmaceutical very costly. For example, for drug discovery, products, different countries, such as the it may require the screening of a large numUnited States, the European Community ber of compounds in order to obtain a few (EC), and Japan have similar but slightly difpotential promising compounds. In practice, ferent sets of regulatory requirements. This it is very likely that these potential promising paper focuses on the United States regulatory compounds may never reach other stages of requirements for drug development. The drug development such as animal studies or United States regulations for drug development are developed based on the Federal Food, Drug and Cosmetic Act (FD&C Act) Presented at the DIA “First International Taipei Sympo- passed in 1938. The FD&C Act requires sium,” August 29-30, 1996, Taipei, Taiwan. Reprint address: Shein-Chung Chow, PhD, Biosta- pharmaceutical companies to submit full retistics and Data Management, Covance, Inc., 210 Car- ports of investigations on the safety of new d
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