Overview
Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of ""Pharmaceutical Dosage Forms: Parenteral Medications"" examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues. This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials. With the contributions of leading experts, volume 3 of ""Pharmaceutical Dosage Forms: Parenteral Medications"" is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
Full Product Details
Author: Kenneth E. Avis ,
Herbert Lieberman (Livingston, New Jersey, USA) ,
Leon Lachman (Lachman Consultants, Westbury, New York) ,
Leon Lachman
Publisher: Taylor & Francis Inc
Imprint: Routledge
Edition: 2nd edition
Dimensions:
Width: 17.80cm
, Height: 3.30cm
, Length: 25.40cm
Weight: 1.020kg
ISBN: 9780824790202
ISBN 10: 0824790200
Pages: 590
Publication Date: 01 April 1993
Audience:
College/higher education
,
Professional and scholarly
,
Postgraduate, Research & Scholarly
,
Professional & Vocational
Format: Hardback
Publisher's Status: Active
Availability: In Print
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Reviews
"". . .a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production. "" ---Pharmaceutical Technology
. . .a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production. ---Pharmaceutical Technology
