Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer
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| Titolo: |
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer
|
| Pubblicazione: | New York : , : Informa Healthcare USA, , 2010 |
| Descrizione fisica: | 1 online resource (292 p.) |
| Disciplina: | 615.19 |
| Soggetto topico: | Generic drugs |
| Drug development | |
| Drugs - Dosage forms | |
| Drugs - Therapeutic equivalency | |
| Soggetto genere / forma: | Electronic books. |
| Altri autori: |
ShargelLeon <1941->
KanferIsadore
|
| Note generali: | Description based upon print version of record. |
| Nota di bibliografia: | Includes bibliographical references and index. |
| Nota di contenuto: | 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 | |
| Sommario/riassunto: | 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 |
| Titolo autorizzato: | Generic drug product development |
| ISBN: | 0-429-13292-1 |
| 1-282-56098-0 | |
| 9786612560989 | |
| 1-4200-2003-X | |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910459270503321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |
Serie:
Drugs and the pharmaceutical sciences ; ; v. 204.