Role of Preformulation in Development of Solid Dosage Forms

Autor: Satheesh Podaralla, Omathanu Perumal
Rok vydání: 2010
Předmět:
Zdroj: Pharmaceutical Sciences Encyclopedia
DOI: 10.1002/9780470571224.pse363
Popis: Preformulation testing has a significant role in a drug discovery and development program, as it provides valuable feedback to the various discovery and development teams in enabling druggability during lead identification and optimization. In a generic setting, preformulation studies are mainly focused on developing a formulation that is bioequivalent to the innovator's product with the main objective of filing an abbreviated new drug application (ANDA). This article focuses on preformulation testing for oral solid dosage forms in a drug discovery setting. Keywords: preformulation testing; abbreviated new drug application (ANDA); drug discovery; oral solid dosage forms
Databáze: OpenAIRE