Computer Assisted New Drug Application (CANDA) Guidance Manual (1994) PDF Download
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Author: DIANE Publishing Company Publisher: DIANE Publishing ISBN: 9780788121203 Category : Languages : en Pages : 362
Book Description
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: DIANE Publishing Company Publisher: DIANE Publishing ISBN: 9780788121203 Category : Languages : en Pages : 362
Book Description
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: Indra K. Reddy Publisher: CRC Press ISBN: 0824751094 Category : Science Languages : en Pages : 406
Book Description
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: National Research Council Publisher: National Academies Press ISBN: 0309154006 Category : Science Languages : en Pages : 246
Book Description
A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.
Author: Orlando Lopez Publisher: Taylor & Francis ISBN: 1351704346 Category : Business & Economics Languages : en Pages : 232
Book Description
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.
Author: DIANE Publishing Company
Author: DIANE Publishing Company
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Author: Indra K. Reddy
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Author: National Research Council
Author: Orlando Lopez