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De Methodo Medendi
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Benefit-Risk Assessment of Medicines
This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is refl...
Method Validation in Pharmaceutical Analysis
This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently i...
Svätí Cyril a Metod
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Spark
Production-targeted Spark guidance with real-world use cases Spark: Big Data Cluster Computing in Production goes beyond general Spark overviews to provide targeted guidance toward using lightning-fast big-data clustering in production. Written by an expert team well-known in the big data community, this book walks you through the challenges in moving from proof-of-concept or demo Spark applications to live Spark in production. Real use cases provide deep insight into common problems, limitations, challenges, and opportunities, while expert tips and tricks help you get the most out of Spark performance. Coverage includes Spark SQL, Tachyon, Kerberos, ML Lib, YARN, and Mesos, with clear, acti...
