Catatan

This book is Volume 4 of the Handbook of Pharmaceutical Manufacturing Formulations series, focusing specifically on the guidelines and manufacturing practices for semisolid pharmaceutical dosage forms, such as ointments, creams, gels, suppositories, and specialized topical preparations. The book is divided into two main parts. Part I, Regulatory and Manufacturing Guidance, discusses regulatory guidelines for post-approval changes involving Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs), manufacturing equipment, stability testing in accordance with International Council for Harmonisation (ICH) standards, and skin irritation and sensitization testing for generic transdermal products. Part II, Formulations of Semisolid Drugs, provides more than 350 examples of semisolid formulations, ranging from generic drug products approved in the United States to various base formulations that can serve as references for developing new pharmaceutical products. Through its comprehensive regulatory guidance, manufacturing information, and formulation examples, this book serves as a valuable reference for pharmaceutical scientists, formulators, researchers, and professionals involved in the development, production, and quality control of semisolid pharmaceutical dosage forms.

Keywords: Pharmaceutical Manufacturing, Semisolid Dosage Forms, Ointments, Creams, Gels, Suppositories, Topical Formulations, Stability Testing, Pharmaceutical Formulation.