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Overview of Drug Product Development

The process for developing drug delivery systems has evolved over the past two decades with more scientific rigor, involving a collaboration of various fields, i.e., biology, chemistry, engineering, and pharmaceutics. Drug products, also commonly known in the pharmaceutical industry as formulations or “dosage forms,” are used for administering the active pharmaceutical ingredient (API) for purposes of assessing safety in preclinical models, early‐ to late‐phase human clinical trials, and for routine clinical/commercial use. This overview discusses approaches for creating small‐molecule API dosage forms, from preformulation to commercial manufacturing. Curr. Protoc. Pharmacol. 55:7.3.1‐7.3.29. © 2011 by John Wiley & Sons, Inc.