Handbook of pharmaceutical manufacturing formulations. Liquid products / Volume 3, (©2009)

• Record Type: Book
• Other Titles: Liquid products
• Further Information: Note: Sarfaraz K. Niazi.
• Other Names: Niazi, Sarfaraz, 1949-
• Contents: Front Cover -- Volume 3; Preface to the Series-Second Edition; Preface to the Series-First Edition; About the Author; Contents; Part I -- Regulatory and Manufacturing Guidance; 1 -- Manufacturing Practice Considerations in Liquid Formulations; 2 -- Oral Solutions and Suspensions; 3 -- The FDA Drug Product Surveillance Program; 4 -- Changes to Approved NDAs and ANDAs; 5 -- Formulation Considerations of Liquid Products; 6 -- Container Closure Systems; 7 -- Material for Containers; 8 -- Stability Testing of New Drug Substances and Products. 9 -- Stability Testing: Photostability Testing of New Drug Substances and Products10 -- Stability Testing for New Dosage Forms; 11 -- Bracketing and Matrixing Designs for Stability Testingof New Drug Substances and Products; 12 -- Evaluation of Stability Data; 13 -- Stability Data Package for Registration Applications in Climatic Zones III and IV; 14 -- EU Guidelines to Good Manufacturing Practice MedicinalProducts for Human and Veterinary Use; 15 -- EDQM Certification; 16 -- Impurities: Guideline for Residual Solvents; 17 -- Electronic Records and Signatures (CFR 21 Part 11 Compliance). 18 -- GMP Audit Template, EU Guidelines19 -- Bioequivalence Testing Protocols; 20 -- Dissolution Testing of Liquid Dosage Forms; 21 -- Approved Excipients in Liquid Forms; Part II -- Manufacturing Formulations; Index; Back Cover -- Volume 3.
• Edition: 2nd ed
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2009
• Copyright Date: 2009
• Extent: 1 online resource (xx, 377 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: 9781420081244; 1420081241
• 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.