03585oam 2200733I 450 991045927050332120200520144314.00-429-13292-11-282-56098-097866125609891-4200-2003-X10.3109/9781420020038 (CKB)2670000000014357(EBL)1405502(SSID)ssj0000360478(PQKBManifestationID)11305258(PQKBTitleCode)TC0000360478(PQKBWorkID)10326421(PQKB)10051629(MiAaPQ)EBC1405502(MiAaPQ)EBC510087(Au-PeEL)EBL1405502(CaPaEBR)ebr10373310(CaONFJC)MIL256098(OCoLC)609861128(OCoLC)647895183(Au-PeEL)EBL510087(EXLCZ)99267000000001435720180420d2010 uy 0engur|n|---|||||txtccrGeneric drug product development specialty dosage forms /edited by Leon Shargel, Isadore KanferNew York :Informa Healthcare USA,2010.1 online resource (292 p.)Drugs and the pharmaceutical sciences ;204Description based upon print version of record.0-8493-7786-2 Includes bibliographical references and index.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 FormsChapter 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 CoverGeneric 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, alongDrugs and the pharmaceutical sciences ;v. 204.Generic drugsDrug developmentDrugsDosage formsDrugsTherapeutic equivalencyElectronic books.Generic drugs.Drug development.DrugsDosage forms.DrugsTherapeutic equivalency.615.19Shargel Leon1941-91098Kanfer Isadore1035380MiAaPQMiAaPQMiAaPQBOOK9910459270503321Generic drug product development2455073UNINA