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010   $a1-282-56098-0
010   $a9786612560989
010   $a1-4200-2003-X
024 7 $a10.3109/9781420020038 
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100   $a20180420d2010      uy             0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 00$aGeneric drug product development $especialty dosage forms /$fedited by Leon Shargel, Isadore Kanfer
210  1$aNew York :$cInforma Healthcare USA,$d2010.
215   $a1 online resource (292 p.)
225 1 $aDrugs and the pharmaceutical sciences ;$v204
300   $aDescription based upon print version of record.
311   $a0-8493-7786-2 
320   $aIncludes bibliographical references and index.
327   $aFront 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
327   $aChapter 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
330   $aGeneric Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along
410  0$aDrugs and the pharmaceutical sciences ;$vv. 204.
606   $aGeneric drugs
606   $aDrug development
606   $aDrugs$xDosage forms
606   $aDrugs$xTherapeutic equivalency
608   $aElectronic books.
615  0$aGeneric drugs.
615  0$aDrug development.
615  0$aDrugs$xDosage forms.
615  0$aDrugs$xTherapeutic equivalency.
676   $a615.19
701   $aShargel$b Leon$f1941-$091098
701   $aKanfer$b Isadore$01035380
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910459270503321
996   $aGeneric drug product development$92455073
997   $aUNINA