Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
Book Description
Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application
Author: Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of Application
Author: Draft Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application
Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 9
Book Description
Guideline on Formatting, Assembling, and Submitting New Drug and Antibiotic Applications
Author: DIANE Publishing CompanyPublisher: DIANE Publishing
ISBN: 0788147846
Category :
Languages : en
Pages : 65
Book Description
Guideline on Formatting, Assembling, and Submitting New Drug and Antibiotic Applications
Author: Drug Development
Author: Charles E. HamnerPublisher: CRC Press
ISBN: 0429552998
Category : Medical
Languages : en
Pages : 319
Book Description
Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.
Pharmaceutical Dosage Forms
Author: Kenneth E. AvisPublisher: Routledge
ISBN: 135142517X
Category : Medical
Languages : en
Pages : 594
Book Description
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.
NIDA Research Monograph
Author: Handbook of Modern Pharmaceutical Analysis
Author: Satinder AhujaPublisher: Academic Press
ISBN: 9780120455553
Category : Medical
Languages : en
Pages : 566
Book Description
This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.
Author: