Pharmaceutical Dosage Forms
Format: Hardcover
ISBN13: 9780824790202
Hardcover|9780824790202
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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.
| ISBN-13 | 9780824790202 |
|---|---|
| ISBN-10 | 0824790200 |
| Weight | 2.51 Pounds |
| Dimensions | 1.27 x 7.01 x 10.00 In |
| List Price | $229.95 |
| Edition | 2nd Edition |
| Format | Hardcover |
|---|---|
| Language | English |
| Pages | 592 pages |
| Publisher | Marcel Dekker |
| Published On | 1993-04-01 |
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