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Record Nr. |
UNINA9910800062003321 |
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Titolo |
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
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Pubbl/distr/stampa |
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New York : , : Informa Healthcare USA, , 2010 |
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ISBN |
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0-429-13292-1 |
1-282-56098-0 |
9786612560989 |
1-4200-2003-X |
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Descrizione fisica |
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1 online resource (292 p.) |
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Collana |
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Drugs and the pharmaceutical sciences ; ; 204 |
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Altri autori (Persone) |
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ShargelLeon <1941-> |
KanferIsadore |
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Disciplina |
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Soggetti |
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Generic drugs |
Drug development |
Drugs - Dosage forms |
Drugs - Therapeutic equivalency |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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 |
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Sommario/riassunto |
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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 |
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