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Basic Method Validation
James O. Westgard
其他書名
Training in Analytical Quality Management for Healthcare Laboratories
出版Westgard QC, 2020
主題Health & Fitness / GeneralMedical / GeneralMedical / Laboratory Medicine
ISBN18869583359781886958333
URLhttp://books.google.com.hk/books?id=Ij6szQEACAAJ&hl=&source=gbs_api
註釋"For 50 years, Dr. James O. Westgard has championed standards of quality and best practices for method validation. In this, the fourth edition of Basic Method Validation, Dr. Westgard and colleagues provide important updates on regulatory requirements, evolving standards of practice, and the latest guidelines from CLSI, FDA, CMS, and ISO: New coverage of the validation and verification of qualitative and semi-quantitative testing, a topic critically important in the age of SARS-COV-2; Update of CLIA regulations and accreditation requirements; Discussion of Laboratory-Developed Tests (LDTs); Full coverage of the different studies necessary for validation and verification; Detailing of strengths of different regression techniques for comparison of methods Fully updated, revised, and expanded, Basic Method Validation also provides online access to graphing tools, videos, and extensive examples of validation and verification. In an era where the quality of methods may be in doubt, the fourth edition is even an more essential reference for the modern laboratory"--