Author : DIANE Publishing Company
Publisher : DIANE Publishing
Page : 362 pages
File Size : 48,69 MB
Release : 1995-08
Category :
ISBN : 9780788121203
Presents CDER Review Division & Discipline review processes at a relatively high level since the conceptual, application, & legal dimensions of electronic submissions remain developmental. Provides a solid framework for constructing CANDA submissions & a perspective for the future growth of electronic submissions.
Author :
Publisher :
Page : 676 pages
File Size : 36,26 MB
Release : 1993
Category : Administrative law
ISBN :
Author :
Publisher :
Page : 182 pages
File Size : 16,28 MB
Release :
Category : Administrative law
ISBN :
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Publisher :
Page : 1896 pages
File Size : 42,53 MB
Release : 1996
Category : Medical care
ISBN :
Author : Indra K. Reddy
Publisher : CRC Press
Page : 406 pages
File Size : 47,27 MB
Release : 2004-03-15
Category : Science
ISBN : 0824751094
Covering every essential element in the development of chiral products, this reference provides a solid overview of the formulation, biopharmaceutical characteristics, and regulatory issues impacting the production of these pharmaceuticals. It supports researchers as they evaluate the pharmacodynamic, pharmacokinetic, and toxicological characteristics of specific enantiomers and chiral drug compounds and addresses in one convenient reference all the major challenges pertaining to drug chirality that have been neglected in the literature. Chirality in Drug Design and Development collects the latest studies from an interdisciplinary team of experts on chiral drug design.
Author :
Publisher :
Page : 836 pages
File Size : 39,22 MB
Release : 2001
Category : Education
ISBN :
Author :
Publisher :
Page : 3054 pages
File Size : 19,18 MB
Release : 2001
Category : American literature
ISBN :
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Publisher :
Page : 1388 pages
File Size : 36,65 MB
Release : 1994
Category : Medicine
ISBN :
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Publisher :
Page : 602 pages
File Size : 41,24 MB
Release : 1994
Category : Science
ISBN :
Author : Orlando Lopez
Publisher : Taylor & Francis
Page : 232 pages
File Size : 44,85 MB
Release : 2018-10-02
Category : Business & Economics
ISBN : 1351704346
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
