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Book Cover
E-book
Author Shargel, Leon

Title Generic Drug Product Development : Specialty Drug Forms
Published New York : Informa Healthcare, 2010

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Description 1 online resource (292 pages)
Contents Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products -- Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms
Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products -- Manufacture and Quality ; Index; Color Insert ; Back Cover
Summary Explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products
Notes Print version record
Subject Generic drugs.
Drug development.
Drugs -- Dosage forms.
Drugs -- Therapeutic equivalency.
Drugs, Generic
Dosage Forms
Therapeutic Equivalency
MEDICAL -- Pharmacology.
Drug development
Drugs -- Dosage forms
Drugs -- Therapeutic equivalency
Generic drugs
Form Electronic book
Author Kanfer, Isadore
ISBN 9781420020038
142002003X