Description |
1 online resource (xi, 275 pages) : illustrations |
Series |
Drugs and the pharmaceutical sciences ; 204 |
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Drugs and the pharmaceutical sciences ; v. 204
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Contents |
1. Introduction / Leon Shargel -- 2. Nonsystemically absorbed oral drug products / Marc Lefebvre -- 3. Topical drug products : development, manufacture and regulatory issues / Mary Beth G. Erstad and Candis Edwards -- 4. Assessment of topical dosage forms intended for local or regional activity / Isadore Kanfer [and others] -- 5. Rectal dosage forms and suppositories / K. Rosh Vora and Mohammed N. AliChisty -- 6. Nasal and inhalation drug products / John Bell and Paul Flanders -- 7. Locally acting nasal and inhalation drug products : regulatory and bioequivalence perspective / Gur Jai Pal Singh -- 8. Transdermal dosage forms / Mario A. Gonzl̀ez and Gary W. Cleary -- 9. Pharmaceutical development of modified-release parenteral dosage forms using bioequivalence (BE), quality by design (QBD), and in vitro in vivo correlation (IVIVC) principles / Siddhesh D. Patil and Diane J. Burgess -- 10. Biosimilar drug products -- manufacture and quality / Suzanne M. Sensabaugh |
Summary |
Explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products |
Bibliography |
Includes bibliographical references and index |
Notes |
Print version record |
Subject |
Generic drugs.
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Drug development.
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Drugs -- Dosage forms.
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Drugs -- Therapeutic equivalency.
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Dosage Forms
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Drugs, Generic
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Biopharmaceutics -- methods
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Therapeutic Equivalency
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Drug development
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Drugs -- Dosage forms
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Drugs -- Therapeutic equivalency
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Generic drugs
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Form |
Electronic book
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Author |
Shargel, Leon, 1941-
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Kanfer, Isadore.
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LC no. |
2009045723 |
ISBN |
142002003X |
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9781420020038 |
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