Handbook of pharmaceutical manufacturing formulations. Semisolid products / Volume 4, (©2009)

• Record Type: Book
• Other Titles: Semisolid products
• Further Information: Note: Sarfaraz K. Niazi.
• Other Names: Niazi, Sarfaraz, 1949-
• 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.
• Edition: 2nd ed
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2009
• Copyright Date: 2009
• Extent: 1 online resource (xxi, 345 pages), illustrations
• Subjects: 615/.19; Drugs -- Dosage forms -- Handbooks, manuals, etc; Drug Compounding; Dosage Forms; Formularies as Topic; Technology, Pharmaceutical; Drugs; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Drugs -- Dosage forms; Handbooks; Electronic books; Handbooks and manuals
• Languages: English
• ISBNs: 9781420081275; 1420081276
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.