Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products

Overview

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.

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Overview

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
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Product Details

  • ISBN-13: 9781420081268
  • Publisher: Taylor & Francis
  • Publication date: 9/21/2009
  • Edition number: 2
  • Pages: 376
  • Product dimensions: 8.80 (w) x 11.10 (h) x 1.20 (d)

Table of Contents

REGULATORY ANDMANUFACTURING 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

MANUFACTURING FORMULATIONS
Regulatory and Manufacturing Guidance

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