Understanding the Interfaces Among Multiple Technical Disciplines: An Increasing Challenge for Regulatory Affairs

Abstract

Successful, rapid, and efficient drug development depends on planning, coordinating, executing, and completing development activities in multiple technical disciplines. The six broadly-defined technical disciplines that comprise drug regulatory applications are: 1. Nonclinical pharmacology and toxicology, 2. Chemistry, manufacturing, and controls, 3. Clinical sciences, 4. Human pharmacokinetics and bioavailability, 5. Statistics, and 6. Microbiology. In the United States, a New Drug Application (NDA) must present an integrated, coherent, and nonconflicting set of information both within each individual technical discipline and across all technical disciplines. An increasing challenge for regulatory affairs professionals is to assure that an integrated, coherent, and nonconflicting set of information is developed across different disciplines. The magnitude of this challenge is increased by the desire for more rapid drug development and the consequent increase in assumptions that are operative at any given time. In this paper, the basic mathematics of combinations is used to calculate the number of pair-wise interfaces among technical disciplines, as well as the number of interfaces among subsets of three disciplines. Examples of pair-wise interfaces between disciplines are presented to illustrate the issues that must be identified, made subject to contingency plans, and resolved on an ongoing basis to assure efficient and successful drug development. Regulatory affairs professionals have a major role in identifying and resolving such issues at multidis-ciplinary interfaces, while also assuring that the method of resolution meets legal and regulatory requirements.