Pharmaceutical Analysis for Small Molecules

Author: Behnam Davani
Publisher: John Wiley & Sons
ISBN: 1119425018
Format: PDF, Mobi
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A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

Handbook of Modern Pharmaceutical Analysis

Author: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780120455553
Format: PDF, Mobi
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This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Pharmaceutical Analysis

Author: David C Lee
Publisher: John Wiley & Sons
ISBN: 1405172991
Format: PDF, Kindle
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The use of analytical sciences in the discovery, development and manufacture of pharmaceuticals is wide-ranging. From the analysis of minute amounts of complex biological materials to the quality control of the final dosage form, the use of analytical technology covers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drug development and manufacture, focusing on the analysis of the active ingredient or drug substance. It provides those joining the industry or other areas of pharmaceutical research with a source of reference to a broad range of techniques and their applications, allowing them to choose the most appropriate analytical technique for a particular purpose. The volume is directed at analytical chemists, industrial pharmacists, organic chemists, pharmaceutical chemists and biochemists.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author: Damian J. Houde
Publisher: Newnes
ISBN: 0444595902
Format: PDF, Mobi
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Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure this book takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help today’s industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered. Presents the reader with a clear understanding of the real world issues and challenges in using these methods. Highlights the capabilities and limitations of each method. Discusses how to best analyze the data generated from these methods. Points out what one needs to look for to avoid making faulty conclusions and mistakes. In total it provides a check list or road map that empowers the industrial scientists as to what they need to be concerned with in order to effectively do their part in successfully developing these new drugs in an efficient and cost effective manner.

A Handbook of Bioanalysis and Drug Metabolism

Author: Gary Evans
Publisher: CRC Press
ISBN: 9780203642535
Format: PDF, ePub, Mobi
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Recent years have seen a greater industrial emphasis in undergraduate and postgraduate courses in the pharmaceutical and chemical sciences. However, textbooks have been slow to adapt, leaving the field without a text/reference that is both instructional and practical in the industrial setting – until now. A Handbook of Bioanalysis and Drug Metabolismis a stimulating new text that examines the techniques, methodology, and theory of bioanalysis, pharmacokinetics, and metabolism from the perspective of scientists with extensive professional experience in drug discovery and development. These three areas of research help drug developers to optimize the active component within potential drugs thereby increasing their effectiveness, and to provide safety and efficacy information required by regulators when granting a drug license. Professionals with extensive experience in drug discovery and development as well as specialized knowledge of the individual topics contributed to each chapter to create a current and well-credentialed text. It covers topics such as high performance liquid chromatography, protein binding, pharmacokinetics and drug–drug interactions. The unique industrial perspective helps to reinforce theory and develop valuable analytical and interpreting skills. This text is an invaluable guide to students in courses such as pharmaceutical science, pharmacology, chemistry, physiology and toxicology, as well as professionals in the biotechnology industry.

Reviews in Pharmaceutical and Biomedical Analysis

Author: Paraskevas D. Tzanavaras
Publisher: Bentham Science Publishers
ISBN: 1608051900
Format: PDF
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Reviews in Pharmaceutical and Biomedical Analysis - Reviews in Pharmaceutical and Biomedical Analysis contains coverage and review of new trends and applications in all areas of pharmaceutical, biomedical and analytical chemistry. Authors have contributed review articles according to their expertise on various relevant topics. The book's aim is to cover important instrumental analytical methods that are applied to the analysis of compounds with pharmaceutical and biomedical interest, including liquid and gas chromatography, electrophoresis & related techniques, mass spectrometry, hyphenated techniques, automated analytical techniques, spectrometry, luminescence, electroanalysis etc. Since the analysis of pharmaceuticals in a variety of matrices (formulations, biological material, environmental samples) is and will continue to be a "hot" topic, such a review book will be of interest to a very broad spectrum of scientists involved in chemistry and medicine.

New Drug Development

Author: J. Rick Turner
Publisher: John Wiley & Sons
ISBN: 047007373X
Format: PDF
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This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.

Characterization of Protein Therapeutics using Mass Spectrometry

Author: Guodong Chen
Publisher: Springer Science & Business Media
ISBN: 1441978623
Format: PDF, Kindle
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This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.

Characterization of Impurities and Degradants Using Mass Spectrometry

Author: Guodong Chen
Publisher: John Wiley & Sons
ISBN: 0470922974
Format: PDF, Mobi
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The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.

Structure Elucidation in Organic Chemistry

Author: Maria-Magdalena Cid
Publisher: John Wiley & Sons
ISBN: 3527664637
Format: PDF, Docs
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Intended for advanced readers, this is a review of all relevant techniques for structure analysis in one handy volume. As such, it provides the latest knowledge on spectroscopic and related techniques for chemical structure analysis, such as NMR, optical spectroscopy, mass spectrometry and X-ray crystallography, including the scope and limitation of each method. As a result, readers not only become acquainted with the techniques, but also the advantages of the synergy between them. This enables them to choose the correct analytical method for each problem, saving both time and resources. Special emphasis is placed on NMR and its application to absolute configuration determination and the analysis of molecular interactions. Adopting a practical point of view, the author team from academia and industry guarantees both solid methodology and applications essential for structure determination, equipping experts as well as newcomers with the tools to solve any structural problem.