| Description |
1 online resource (xxi, 345 pages) : illustrations |
| Contents |
Part I -- Regulatory and Manufacturing Guidance -- 1 -- Waiver of In Vivo Bioequivalence Study -- 2 -- Quality Risk Management -- 3 -- Pharmaceutical Quality System -- 4 -- Pharmaceutical Development -- 5 -- Pharmaceutical Development in CTD -- 6 -- Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms:Manufacturing Equipment -- 7 -- GOOD Manufacturing Practice Guide for Active Pharmaceutical Ingredients -- 8 -- Validation of Analytical Procedures -- 9 -- Validation of Analytical Procedures: Methodology -- 10 -- Bioequivalence Testing of Topical Drugs -- 11 -- Good Manufacturing Requirements for Active Pharmaceutical Ingredients -- 12 -- FDA Active Pharmaceutical Ingredient Manufacturing Facility Inspection -- 13 -- Specifications: Test Procedures and Acceptance Criteria for New DrugSubstances and New Drug Products -- 14 -- Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products -- 15 -- Impurities in New Drug Substances -- 16 -Impurities in New Drug Products -- 17 -- Formulation Factors in Semisolid Dosage Forms -- 18 -- GMP Audit Template, EU Guidelines -- 19 -- Dissolution Testing of Semisolid Dosage Forms -- 20 -- Approved Excipients in Semisolid Dosage Forms -- Part II -- Manufacturing Formulations -- Regulatory and Manufacturing Guidance -- Index -- Back Cover |
| Summary |
The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in these formulations. Highlights from Semisolid Products, Volume Four include:coverage of over 350 formulationsvaluable information on the difficult area of compliancechanges to appr |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drugs -- Dosage forms -- Handbooks, manuals, etc
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Drugs -- Dosage forms.
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Pharmaceutical technology.
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Drug Compounding
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Dosage Forms
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Formularies as Topic
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Technology, Pharmaceutical
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MEDICAL -- Drug Guides.
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Pharmaceutical technology
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Drugs -- Dosage forms
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| Genre/Form |
handbooks.
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manuals (instructional materials)
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Handbooks and manuals
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Handbooks and manuals.
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Guides et manuels.
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| Form |
Electronic book
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| ISBN |
9781420081275 |
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1420081276 |
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