Handbook of pharmaceutical manufacturing formulations. Sterile products / Volume 6, (©2009)

• Record Type: Book
• Other Titles: Sterile products
• Further Information: Note: Sarfaraz K. Niazi.
• Other Names: Niazi, Sarfaraz, 1949-
• Contents: Front Cover -- Volume 6; Preface to the Series-Second Edition; Preface to the Series-First Edition; About the Author; Part I -- Regulatory and Manufacturing; 1 -- Sterile Manufacturing Formulations Template; 2 -- GMP Audit Template, EU Guidelines; 3 -- Inspection of Sterile Product Manufacturing Facilities; 4 -New Drug Application for Sterilized Products; 5 -- Validation of Cleaning Process; 6 -- Viral Safety Evaluation of Biotechnology ProductsDerived from Cell Lines of Human or Animal Origin; 7 -- Analysis of the Expression Construct in Cells Usedfor Production of rDNA-Derived Protein Products. 8 -- Stability Testing of Biotechnological/Biological Products9 -- Derivation and Characterization of Cell Substrates Used forProduction of Biotechnological/Biological Products; 10 -- Comparability of Biotechnological/Biological ProductsSubject to Changes in Their Manufacturing Process; 11 -- Specifications: Test Procedures and Acceptance Criteriafor Biotechnological/Biological Products; 12 -- Essential Clean-Room Design Elements; 13 -- Approved Excipients in Sterile Dosage Forms; Part II -- Manufacturing Formulations; Index; Back Cover.
• Edition: 2nd ed
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2009
• Copyright Date: 2009
• Extent: 1 online resource (xxi, 434 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: 9781420081312; 1420081314
• 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.