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.

Principles and Practice of Bioanalysis

Author: Richard F. Venn
Publisher: CRC Press
ISBN: 9780748408429
Format: PDF, ePub, Docs
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Principles and Practice of Bioanalysis provides a guide to the methods available and the techniques currently used in this field. It provides up to the minute information and guidance on the methods and strategy used in developing and running ultra-trace analyses for drugs, metabolites and other substances. The authors writes in an informal and didactic style, offering a logical path through the problems of small molecule (bio)analysis and enables readers to choose appropriate methods of analysis for their needs. Principles and Practice of Bioanalysis provides an overview of analytical methods for analytical scientists within the pharmaceutical industry, research and development, the agrochemical industry, and scientists in the health service, biology and biochemistry. It also gives postgraduate students a useful reference for their research methods.

Handbook of LC MS Bioanalysis

Author: Wenkui Li
Publisher: John Wiley & Sons
ISBN: 111867135X
Format: PDF, Kindle
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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.

Understanding Bioanalytical Chemistry

Author: Victor A. Gault
Publisher: John Wiley & Sons
ISBN: 1118684893
Format: PDF, ePub, Mobi
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"The title captures the ethos and content precisely. It brings basic chemistry into real life with examples that illustrate how chemical principals are inherent to bioanalytical procedures, making them accessible to readers with a background in life sciences." –Microbiology Today, July 2009 “… a good overview of the basic strategies to tackle the complexity of analysis in biological environments and provides some illustrative examples for a better understanding of the theoretical concepts… provides a fundamental introduction to the tools adopted by life and health scientists in the evolving and exciting new age of “omics” specifically applied to the diagnosis, treatment, cure and prevention of disease…” –Analytical and Bioanalytical Chemistry, October 2009 Although chemistry is core to the life and health sciences, it is often viewed as a challenging subject. Conventional textbooks tend to present chemistry in a way that is not always easily accessible to students, particularly those coming from diverse educational backgrounds, who may not have formally studied chemistry before. This prompted the authors to write this particular textbook, taking a new, fresh and innovative approach to teaching and learning of chemistry, focusing on bioanalysis to set knowledge in context. This textbook is primarily targeted to undergraduate life and health science students, but may be a useful resource for practising scientists in a range of disciplines. In this textbook the authors have covered basic principles, terminology and core technologies, which include key modern experimental techniques and equipment used to analyse important biomolecules in diagnostic, industrial and research settings. Written by two authors with a wealth of experience in teaching, research and academic enterprise, this textbook represents an invaluable tool for students and instructors across the diverse range of biological and health science courses. Key Features: Innovative, stand alone teaching and learning resource to enhance delivery of undergraduate chemistry provision to life and health scientists. Develops student knowledge and understanding of core concepts with reference to relevant, real-life, examples. Clearly written and user-friendly, with numerous full colour illustrations, annotated images, diagrams and tables to enhance learning. Incorporates a modern approach to teaching and learning to motivate the reader and encourage student-centred learning. Dr Victor Gault has been named recipient of the Rising Star Award 2009 by the internationally acclaimed European Association for the Study of Diabetes (EASD).

Antibody Drug Conjugates

Author: Kenneth J. Olivier, Jr.
Publisher: John Wiley & Sons
ISBN: 111906080X
Format: PDF, ePub, Docs
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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

Clinical Applications of Monoclonal Antibodies

Author: Ron Hubbard
Publisher: Springer Science & Business Media
ISBN: 1461315735
Format: PDF, ePub, Mobi
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Immunology has come a long way in the hundred or so years since the general concepts were first enuciated by Metchnikoff, Ehrlich, Von Bebring and others, One of the landmarks in this progress was the invention and development of monoclonal antibody secreting hybridomas by Milstein and bis co-workers in Cambridge. Unlike most modern inventions of this importance that of monoclonal antibody production was made available to the scientific community tbroughout the world unimpeded by patent protection. This may explain tbe unusual rapidity witb which it has been applied to the benefit of mankind in general. This book, representing as it does the proceedings of tbe first International Symposium to be held on the clinical appli cations of monoclonal antibodies, shows just how much bas been achieved within the space of little more than a decade. The enormaus promise of monoclonal antibody technology, which became apparent soon after its discovery, has already progressed a long way towards fulfillment. The contributors to tbis volume, all of whom are actively engaged in monoclonal antibody development and application, represent the state of the art. Professor Vincent Marks V INTRODUCTION It has been some twelve years since the pioneering experiments of Köhler and Milstein led to the discovery of monoclonal antibodies. Single molecular species antiborlies with desired specificities could be produced by the fusion of antibody - producing cells with neoplastic cells.

FDA Bioequivalence Standards

Author: Lawrence X. Yu
Publisher: Springer
ISBN: 1493912526
Format: PDF, Mobi
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This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Developing Solid Oral Dosage Forms

Author: Yihong Qiu
Publisher: Academic Press
ISBN: 0128026375
Format: PDF, Mobi
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Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Formulating Poorly Water Soluble Drugs

Author: Robert O. Williams III
Publisher: Springer
ISBN: 3319426095
Format: PDF, Kindle
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The objective of this volume is to consolidate within a single text the most current knowledge, practical methods, and regulatory considerations pertaining to formulations development with poorly water-soluble molecules. A pharmaceutical scientist’s approach toward solubility enhancement of a poorly water-soluble molecule typically includes detailed characterization of the compound’s physiochemical properties, solid-state modifications, advanced formulation design, non-conventional process technologies, advanced analytical characterization, and specialized product performance analysis techniques. The scientist must also be aware of the unique regulatory considerations pertaining to the non-conventional approaches often utilized for poorly water-soluble drugs. One faced with the challenge of developing a drug product from a poorly soluble compound must possess at minimum a working knowledge of each of the abovementioned facets and detailed knowledge of most. In light of the magnitude of the growing solubility problem to drug development, this is a significant burden especially when considering that knowledge in most of these areas is relatively new and continues to develop

Cancer and Chemoprevention An Overview

Author: Summya Rashid
Publisher: Springer
ISBN: 9811025797
Format: PDF, Docs
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This book focuses on the most recent, relevant, comprehensive and significant advances in cancer and chemo prevention. It broadly discusses cancer, its hallmarks and classification, molecular mechanisms of outbreak, contributing factors, role of oxidative stress, inflammatory mediators and evading apoptosis, which leads to the progression of disease. Though modern medicine has left us with no option to treat this deadly disease due to drawbacks associated with conventional treatment – like its non-targeted nature, drug resistance, varied organ toxicities and unaffordability – chemoprevention offers a viable therapeutic window. Given chemoprevention’s importance in the present scenario, the book highlights various chemo preventive strategies currently used in the management of cancer; a selection of novel chemo preventive agents used at clinics and in the pre-clinical stage; hurdles to effective chemoprevention; future prospects and the road ahead. It offers a valuable guide for all graduate students and researchers seeking information on cancer and chemoprevention in general, irrespective of the specific type/pathways involved in its onset.