practical approaches method validation (27 risultati)

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Condizione: New. pp. xiv + 399.

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Condizione: New. This is a Brand-new US Edition. This Item may be shipped from US or any other country as we have multiple locations worldwide.

Condizione: New. pp. xiv + 399 Illus.

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Condizione: New. pp. xiv + 399.

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Hardcover. Condizione: new. Hardcover. Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performancecoverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzersand offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements. All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.

Hardback. Condizione: New. New copy - Usually dispatched within 4 working days. 798.

Condizione: New. All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Num Pages: 416 pages, Illustrations. BIC Classification: PDN; PNF. Category: (P) Professional & Vocational. Dimension: 239 x 160 x 26. Weight in Grams: 768. . 2010. 1st Edition. Hardcover. . . . .

Hardcover. Condizione: new. Hardcover. Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performancecoverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzersand offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements. All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.

Gebunden. Condizione: New. CHUNG CHOW CHAN, PhD, is a Consultant for CCC Consulting, and the former president of the Calibration & Validation Group, a nonprofit organization dedicated to the art and science of instrument calibration and method validation.HERMAN LAM, PhD, is the Princ.

Hardcover. Condizione: Brand New. 1st edition. 399 pages. 9.29x6.30x1.10 inches. In Stock.

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Condizione: New. Brand New! Fast Delivery This is an International Edition and ship within 24-48 hours. Deliver by FedEx and Dhl, & Aramex, UPS, & USPS and we do accept APO and PO BOX Addresses. Order can be delivered worldwide within 7-10 days and we do have flat rate for up to 2LB. Extra shipping charges will be requested if the Book weight is more than 5 LB. This Item May be shipped from India, United states & United Kingdom. Depending on your location and availability.

Condizione: New. All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Num Pages: 416 pages, Illustrations. BIC Classification: PDN; PNF. Category: (P) Professional & Vocational. Dimension: 239 x 160 x 26. Weight in Grams: 768. . 2010. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland.

Buch. Condizione: Neu. Neuware - All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Advance Technologies in Instrumentation, Qualification, Performance, Verification and Analytical Methods Validation skillfully explains important, but advanced, techniques of method validation and instrument performance. The book covers validation of methods for significant new or evolving procedures, such as proteomic assays, rapid microbial identification, and process analytical technologies, making this text a must-read for analysts, scientists, engineers, technologists, and technical managers.

Hardcover. Condizione: new. Hardcover. Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performancecoverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzersand offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements. All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Shipping may be from our Sydney, NSW warehouse or from our UK or US warehouse, depending on stock availability.

Hardcover. Condizione: New. ISBN:9780470121948.