Descrição
- 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. – CONTENTS.: Quality assurance, Samir A. Hanna; records and reports, David C. Fry and Karl L. Hofmann; particulate matter, Patrick P. DeLuca and Julius Z. Knapp; validation of sterilization processes and sterile products, James Agalloco and James Akers; federal regulation of parenterals, Jonas L. Bassen et al; systematic audits of parenteral drug good manufacturing practices, Ronald F. Tetzlaff; medical devices – design, manufacture, and quality control, David H. Wayt; quality assurance for Carl
- por
- Capa dura : 590 paginas
- ISBN-10 : 0824790200
- ISBN-13 : 9780824790202
- Livro sem uso, com paginas amareladas e um pouco sujas pelo tempo – capa, contracapa, bordas e paginas integras. sem marcas, grifos, marcações ou qualquer tipo de detalhe que possa interferir na leitura ou pesquisa – Conteudo perfeito
