Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products, 2nd Edition (Hardback) book cover

Handbook of Pharmaceutical Manufacturing Formulations

Semisolid Products, 2nd Edition

By Sarfaraz K. Niazi

CRC Press

376 pages | 3 B/W Illus.

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Hardback: 9781420081268
pub: 2009-09-21
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pub: 2016-04-19
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Description

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

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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology