Tekst achterflap

This book is intended to cover the fundamental and practical aspects of regulated bioanalysis. The editors are seeking leading scientists in the field to participate in the development of this book, which we envision as a “one of a kind” contribution to our field. The book is intended for students in the pharmaceutical sciences, chemistry, biology and related scientific disciplines interested in bioanalysis, as well as working scientists new to the field of regulated bioanalysis.  It will also serve as a primer for those experienced in the field. The depth of the book will seek to give its audience a solid foundation of knowledge in regulated bioanalysis which can be leveraged further with “hands on” experience.  Understanding that bioanalytical global regulations evolve, the book is not intended as a deep-dive into regulatory language nuances but rather to be an educational text on conducting defendable and auditable science to support modern bioanalysis.

Following an introduction to the topic by the editors, the book then covers “non-scientific” aspects of the topic area including the regulations governing this work, logistical and operational aspects of running a regulated bioanalytical laboratory and appropriate laboratory documentation. Next a description of the typically encountered types of bioanalytical samples, analytes and their attributes is provided. This information then sets the stage for a detailed discussion of the analytical platforms and assay types used in the regulated bioanalysis of small and large molecules. Also provided is a discussion of the different analytical phases of the bioanalytical process (i.e. method development including various strategies, pre-study validation and sample analysis).

Beschrijving

The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field.  The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The  content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.  

Biografie

Mario Rocci earned a Ph.D. in Pharmaceutics and a B.S. in Pharmacy from the State University of New York at Buffalo. He then joined Prevalere and developed the Pharmaceutical and Chemical Analysis business sector. Mario is well known throughout the pharmaceutical industry and has served as the President of the American Association of Pharmaceutical Scientists (AAPS), a professional society of over 13,000 members. He also serves on the Board of Pharmaceutical Sciences for the International Pharmaceutical Federation (FIP) and is Chairman of the Board of the Product Quality Research Institute (PQRI). Dr. Rocci has authored over 125 scientific publications and has extensive experience in the pharmaceutical sciences and the regulatory requirements of the FDA. He has over 25 years of experience in the pharmaceutical industry.

Kenmerk

A one of a kind contribution to the field that places fundamental bioanalytical science in context with current scientific and regulatory practices, its challenges and ongoing developments Leading scientists in the field to development this book Presents predictive toxicology as one of the most complex to analyze in terms of herbal medicines Includes supplementary material: sn.pub/extras

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