The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in these formulations.

Highlights from Semisolid Products, Volume Four include:

• coverage of over 350 formulations
• valuable information on the difficult area of compliance
• changes to approved new drug applications and abbreviated new drug applications
• the evolving guidelines of ICH and when to conduct a regulatory review

Contents

Section I: Regulatory and Manufacturing Guidance

Chapter 1: Changes to Approved New Drug Applications or Abbreviated New Drug Applications

• Reporting Categories
• General Requirements
• Assessing the Effect of Manufacturing Changes
• Components and Composition
• Manufacturing Sites
• Manufacturing Process
• Specifications
• Package
• Labeling
• Miscellaneous Changes
• Multiple Related Changes

Chapter 2: Postapproval Changes to Semisolid Drugs

• Preservative
• Manufacturing Changes
• Process
• Manufacturing Site

Chapter 3: Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment

• Particle Size Reduction and Separation
• Mixing
• Transfer
• Packaging

Chapter 4: Stability Testing of Drug Substances and Drug Products

• Stability Testing for New Drug Applications
• Stability Testing for Abbreviated NDAs
• Stability Testing for Investigational Ndas
• Approved Stability Protocol
• Reporting Stability Data
• Specific Stability Topics
• Considerations for Specific Dosage Forms
• Stability Testing for Postapproval Changes

Chapter 5: Guidelines for Evaluation of Stability Data in Retest Periods

• Guidelines
• Decision Tree for Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products (excluding frozen products)

Chapter 6: Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products

• Study Designs

Chapter 7: Photosafety Testing

• Background
• Testing Considerations
• Testing For Enhancement of UV-Associated Skin Carcinogenesis (Direct Photochemical Carcinogenicity or Indirect Effects In Skin)

Chapter 8: Guidance on Formulating Semisolid Drugs

• Potency Uniformity
• Equipment And Production Control
• Cleaning Validation
• Microbiological
• Change Control
• Transdermal Topical Products

Section II: Formulations of Semisolid Drugs

Chapter 9
Chapter 10
Chapter 11

Index

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