Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty dru
Introduction. Non-Systemically Absorbed Oral Drug Products. Topical Drugs. Nasal and Inhalation Drug Products. Transdermal Drug Delivery. Modified Release Parenteral Drug Products. Generic Biologics.