Pharmaceutical Dosage Forms

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.