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Handbook of Pharmaceutical Manufacturing Formulations, Second Ed
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Handbook of Pharmaceutical Manufacturing Formulations, Second Ed

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Descripción del producto

Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: Six-Volume Set,by Sarfaraz K. Niazi,Available to Purchase,Published: September 2009,Second Edition,2094 pages,Format: Hardcover,Size: 8.5" x 11" 18 Black and White Illustrations

Contents:

Volume 1

Part I. Regulatory And Manufacturing Considerations

  • Bioequivalence Testing Rationale and Principles
  • Bioequivalence Testing Protocols-FDA-Compressed Dosage Forms
  • GMP Audit Template, EU Guidelines
  • Guidance on Formulating Compressed Solids
  • Appendix I Dissolution Testing Requirements of Compressed Dosage Forms
  • Appendix II Approved Excipients in Compressed Solid Dosage Forms

Part II. Manufacturing Formulations

Part III. Tablet Coating Formulations

Part IV. Composition Of Proprietary Products Approved In The US

Volume 2

Part I. Regulatory And Manufacturing Guidelines

  • U.S. FDA Good Manufacturing Practices
  • GMP Audit Template, EU Guidelines 27
    Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use
    Process Validation: General Principles and Practices
    Bioequivalence Regulatory Compliance
    Bioequivalence Regulatory Review Process and Audit
    EU Guidelines to Good Manufacturing Practice
    Preapproval Inspections
    Formulation Factors in Uncompressed Dosage Forms
    Bioequivalence Testing Protocols
    Dissolution Testing of Uncompressed Solid Dosage Forms
    Approved Excipients in Uncompressed Solid Dosage Forms

Part II Manufacturing Formulations

Volume 3

Part I Regulatory And Manufacturing Guidance

  • Manufacturing Practice Considerations in Liquid Formulations
  • Oral Solutions and Suspensions
  • The FDA Drug Product Surveillance Program
  • Changes to Approved NDAs and ANDAs
  • Formulation Considerations of Liquid Products
  • Container Closure Systems
  • Material for Containers
  • Stability Testing of New Drug Substances and Products
  • Stability Testing: Photostability Testing of New Drug Substances and Products
  • Stability Testing for New Dosage Forms
  • Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
  • Evaluation of Stability Data
  • Stability Data Package for Registration Applications in Climatic Zones III and IV
  • EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
  • EDQM Certification
  • Impurities: Guideline for Residual Solvents
  • Electronic Records and Signatures (CFR 21 Part 11 Compliance)
  • GMP Audit Template, EU Guidelines
  • Bioequivalence Testing Protocols
  • Dissolution Testing of Liquid Dosage Forms
  • Approved Excipients in Liquid Forms

Part II Manufacturing Formulations

Volume 4

Part I. Regulatory And Manufacturing Guidance

  • Waiver of In Vivo Bioequivalence Study
  • Quality Risk Management
  • Pharmaceutical Quality System
  • Pharmaceutical Development
  • Pharmaceutical Development in CTD
  • Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment
  • Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • Validation of Analytical Procedures
  • Validation of Analytical Procedures: Methodology
  • Bioequivalence Testing of Topical Drugs
  • Good Manufacturing Requirements for Active Pharmaceutical Ingredients
  • FDA Active Pharmaceutical Ingredient Manufacturing Facility Inspection
  • Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
  • Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products
  • Impurities in New Drug Substances
  • Impurities in New Drug Products
  • Formulation Factors in Semisolid Dosage Forms
  • GMP Audit Template, EU Guidelines
  • Dissolution Testing of Semisolid Dosage Forms
  • Approved Excipients in Semisolid Dosage Forms

Part II. Manufacturing Formulations

Volume 5

Part I Regulatory Guidance

  • EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use
  • EDQM Certification
  • GMP Audit Template, EU Guidelines
  • WHO Good Manufacturing Guidelines
  • Solid Oral Dosage Forms Validation
  • Current Regulatory Status of Over-the-Counter Products

Part II Manufcturing Formulations

Part III Tablet Coating Formulations

Volume 6

Part I Regulatory And Manufacturing

  • Sterile Manufacturing Formulations Template
  • GMP Audit Template, EU Guidelines
  • Inspection of Sterile Product Manufacturing Facilities
  • New Drug Application for Sterilized Products
  • Validation of Cleaning Process
  • Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
  • Analysis of the Expression Construct in Cells Used for Production of rDNA-Derived Protein Products
  • Stability Testing of Biotechnological/Biological Products
  • Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
  • Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
  • Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
  • Essential Clean-Room Design Elements
  • Approved Excipients in Sterile Dosage Forms

Part II Manufacturing Formulations


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