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

• Sarfaraz K. Niazi,
  He has been teaching and conducting research in the pharmaceutical industry for over 35 years. He has authored hundreds of scientific papers, textbooks, and presentations on the topics of pharmaceutical formulation, biopharmaceutics, and pharmacokinetics of drugs. He is also an inventor with scores of patents in the field of drug and dosage form delivery systems; he is also licensed to practice law before the U.S. Patent and Trademark Office. Having formulated hundreds of products from the most popular consumer entries to complex biotechnology-derived products, he has accumulated a wealth of knowledge in the science and art of formulating and regulatory filings of investigational new drugs (INDs) and new drug applications (NDAs). Dr. Niazi advises the pharmaceutical industry internationally on issues related to formulations, cGMP compliance, pharmacokinetics and bioequivalence evaluation, and intellectual property issues (http://www.pharmsci.com).