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Generic Drug Product Development

- Specialty Dosage Forms

About Generic Drug Product Development

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 drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

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  • Language:
  • English
  • ISBN:
  • 9780367384395
  • Binding:
  • Paperback
  • Pages:
  • 288
  • Published:
  • October 14, 2019
  • Dimensions:
  • 152x229x0 mm.
  • Weight:
  • 539 g.
Delivery: 1-2 weeks
Expected delivery: December 13, 2024
Extended return policy to January 30, 2025

Description of Generic Drug Product Development

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 drug products to brand name alternatives.

The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.

The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

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