Analytical Method Validation : QbD
Lawrence A. Wilson
Sold by AHA-BUCH GmbH, Einbeck, Germany
AbeBooks Seller since 14 August 2006
New - Hardcover
Condition: New
Ships from Germany to U.S.A.
Quantity: 2 available
Add to basketSold by AHA-BUCH GmbH, Einbeck, Germany
AbeBooks Seller since 14 August 2006
Condition: New
Quantity: 2 available
Add to basketnach der Bestellung gedruckt Neuware - Printed after ordering - This book contains essays on data integrity.Data integrity is the most basic element of work in any scientific discipline.Nothing of lasting value in the hard sciences (physics, chemistry, biologyastronomy, et al.) lacks integrity in the data used to support the premisesthe logical arguments proposed, and the conclusions drawn. The point ofvalidation is, after all, to ensure that all results obtained and reported aretrue.The original premise of our book was to merge the global standard forpharmaceutical analytical methods for regulatory applications [ICHQ2(R1)] with contemporary thinking on ensuring data quality bythoroughly understanding a method and its intended application (QbD).During a preproduction meeting, an incisive question led to expanding thescope of the original five chapters: 'Can this be applied to fields other thanpharmaceuticals ' The answer was: Yes.Three chapters were added to explore the applications of Quality by Designtheory to real world problems that are bound not only by regulations, but bybusiness constraints, professional ethics, time, resources, and technology. Theymay serve as case studies for classes of advanced students.The scientific approach is rigorous, drawing on, and integrating, classical wetand modern instrumental analytical chemistry knowledge. The reasoning isdetailed and well-documented. Examples are carefully explained. Two arebased on historical events. The other is a problem that is not yet fully resolveddespite its importance and significant risks to human health globally.The tone throughout is conversational. It is intended to involve studentsand any reader who has a vested interest in data integrity, which includes theglobal scientific communities from academia, industry, and government, andproducers and consumers of quantitative measurements and the goods andservices obtained by their use.The objective is to impart an intuitive understanding of method validation:planning, execution, and documentationwith examples of practices andproblems, and with practical strategies for addressing both.A special feature is the inclusion of 'Hints' - brief comments offeringexperience-based advice acquired while developing, validating, reviewing, andauditing analytical methods (and data) in a variety of industriesand countries.
Seller Inventory # 9798987021200
Analytical Method Validation: QbD is a map for the journey from method
design and development to lab experiments to data analysis and proper
documentation. Practical examples of Validation Protocols and associated
Reports, along with case studies across a range of applications, are
explored.
"About this title" may belong to another edition of this title.
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