Regulated Bioanalysis Fundamentals and Practice

Author: Mario L. Rocci Jr.
Publisher: Springer
ISBN: 3319548026
Format: PDF
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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.

Handbook of LC MS Bioanalysis

Author: Wenkui Li
Publisher: John Wiley & Sons
ISBN: 111867135X
Format: PDF
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Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.

Targeted Biomarker Quantitation by LC MS

Author: Naidong Weng
Publisher: John Wiley & Sons
ISBN: 1119413060
Format: PDF
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The first book to offer a blueprint for overcoming the challenges to successfully quantifying biomarkers in living organisms The demand among scientists and clinicians for targeted quantitation experiments has experienced explosive growth in recent years. While there are a few books dedicated to bioanalysis and biomarkers in general, until now there were none devoted exclusively to addressing critical issues surrounding this area of intense research. Target Biomarker Quantitation by LC-MS provides a detailed blueprint for quantifying biomarkers in biological systems. It uses numerous real-world cases to exemplify key concepts, all of which were carefully selected and presented so as to allow the concepts they embody to be easily expanded to future applications, including new biomarker development. Target Biomarker Quantitation by LC-MS primarily focuses on the assay establishment for biomarker quantitation—a critical issue rarely treated in depth. It offers comprehensive coverage of three core areas of biomarker assay establishment: the relationship between the measured biomarkers and their intended usage; contemporary regulatory requirements for biomarker assays (a thorough understanding of which is essential to producing a successful and defendable submission); and the technical challenges of analyzing biomarkers produced inside a living organism or cell. Covers the theory of and applications for state-of-the-art mass spectrometry and chromatography and their applications in biomarker analysis Features real-life examples illustrating the challenges involved in target biomarker quantitation and the innovative approaches which have been used to overcome those challenges Addresses potential obstacles to obtain effective biomarker level and data interpretation, such as specificity establishment and sample collection Outlines a tiered approach and fit-for-purpose assay protocol for target biomarker quantitation Highlights the current state of the biomarker regulatory environment and protocol standards Target Biomarker Quantitation by LC-MS is a valuable resource for bioanalytical scientists, drug metabolism and pharmacokinetics scientists, clinical scientists, analytical chemists, and others for whom biomarker quantitation is an important tool of the trade. It also functions as an excellent text for graduate courses in pharmaceutical, biochemistry and chemistry.

Pharmacology

Author: Miles Hacker
Publisher: Academic Press
ISBN: 9780080919225
Format: PDF, Mobi
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Pharmacology meets the rapidly emerging needs of programs training pharmacologic scientists seeking careers in basic research and drug discovery rather than such applied fields as pharmacy and medicine. While the market is crowded with many clinical and therapeutic pharmacology textbooks, the field of pharmacology is booming with the prospects of discovering new drugs, and virtually no extant textbook meets this need at the student level. The market is so bereft of such approaches that many pharmaceutical companies will adopt Hacker et al. to help train new drug researchers. The boom in pharmacology is driven by the recent decryption of the human genome and enormous progress in controlling genes and synthesizing proteins, making new and even custom drug design possible. This book makes use of these discoveries in presenting its topics, moving logically from drug receptors to the target molecules drug researchers seek, covering such modern topics along the way as side effects, drug resistance, pharmacogenomics, and even nutriceuticals, one in a string of culminating chapters on the drug discovery process. The book is aimed at advanced undergraduates and beginning graduate students in medical, pharmacy, and graduate schools looking for a solid introduction to the basic science of pharmacology and envisioning careers in drug research. Uses individual drugs to explain molecular actions Full color art program explains molecular and chemical concepts graphically Logical structure reflecting the current state of pharmacology and translational research Covers such intricacies as drug resistance and cell death Consistent format across chapters and pedagogical strategies make this textbook a superior learning tool

Antibody Drug Conjugates

Author: Kenneth J. Olivier, Jr.
Publisher: Wiley
ISBN: 9781119060680
Format: PDF, Kindle
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Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development

Drug Discovery and Evaluation Methods in Clinical Pharmacology

Author: Hans Georg Vogel
Publisher: Springer Science & Business Media
ISBN: 3540898905
Format: PDF, ePub, Mobi
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These volumes are a landmark in the continuously changing world of drugs an easy-to-use, method-oriented overview on all aspects of clinical pharmacology Essential reading for pharmacologists, physicians, medicinal chemists and pharmacists at research institutes and in industry of use for governmental institutions and committees working on official guidelines for drug evaluation worldwide Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. the effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. the a

The world of learning 2001

Author: 51st Ed
Publisher: Routledge
ISBN: 9781857430844
Format: PDF, Mobi
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The World Of Learning 2000 lists some 30,000 academic institutions and details more than 200,000 staff and officials. It provides extensive coverage of over 3,000 universities, colleges and other centers of learning. It has information on over 400 international cultural, scientific and educational organizations.