Sinossi
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.
Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.
Informazioni sull'autore
LAWRENCE A. WILSON is a Managing Partner of Mariner Analytical LLC. He received undergraduate degrees in Chemistry (BS) and Psychology (BA) from the State University of New York at Oswego, MS in Medicinal Chemistry from Stevens Institute of Technology (with Dr. Ajay K. Bose and Dr. M.S. Manhas), and MBA in Marketing and Management from Fairleigh Dickinson University (thesis: Mathematical Tools for Decision Quality Enhancement). He studied Applied Chemistry at the University of Texas at Arlington on the D.Sc. track and mentored doctoral candidates in a then-novel, work-study program in his research laboratory. He has worked in diverse industries, including: fine chemical manufacturing, heavy industries [mining, building materials (cement, gypsum, roofing, glass), paper], flavors and fragrances, pharmaceuticals, pesticides, polymers (and more) at the laboratory bench, led global Teams, managed research and manufacturing facilities, contributed to multiple marketing applications for successful drugs, and advised on policy - in particular, organizational redesign to accelerate product development. Over the last two decades, he has consulted domestically and globally - chiefly within the pharmaceutical industry - at research, manufacturing/ packaging, and clinical trial sites, with a consistent focus on ensuring data integrity and data quality.
Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.
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Condizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. KlappentextThis 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, biology,astronomy, et al.) lacks i. Codice articolo 793048287
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Buch. Condizione: Neu. Analytical Method Validation | QbD | Lawrence A. Wilson (u. a.) | Buch | Gebunden | Englisch | 2022 | wessex, inc. | EAN 9798987021200 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand. Codice articolo 126355673
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Buch. Condizione: Neu. nach 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. Codice articolo 9798987021200
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