Author: Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
Book Description
ISPE Good Practice Guide
Author: Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
Book Description
ISPE Good Practice Guide
Author: IspeISPE Good Practice Guide
Author: International Society of Pharmaceutical EngineersPublisher:
ISBN: 9781936379422
Category : Laboratories
Languages : en
Pages : 172
Book Description
ISPE Good Practice Guide
Author: IspeISPE Good Practice Guide
Author: IspeISPE Good Practice Guide
Author: IspeOzone Sanitization of Pharmaceutical Water Systems
Author: International Society for Pharmaceutical EngineeringPublisher:
ISBN: 9781936379446
Category :
Languages : en
Pages : 140
Book Description
GAMP Good Practice Guide
Author: Publisher: Ispe Headquarters
ISBN: 9781931879422
Category : Technology & Engineering
Languages : en
Pages :
Book Description
Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQPublisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
ICH Quality Guidelines
Author: Andrew TeasdalePublisher: John Wiley & Sons
ISBN: 1118971132
Category : Medical
Languages : en
Pages : 624
Book Description
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)