Download or read book Drug Discovery and Evaluation Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Download or read book Drug Discovery and Evaluation written by Hans G. Vogel and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 790 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference book contains a comprehensive selection of the most frequently used assays for reliably detecting pharmacological effects of potential drugs, including tests for cardiovascular, analgesic, psychotropic, metabolic, endocrine, respiratory, renal, and immunomodulatory activities. Each of the over 700 assays comprises a detailed protocol with the purpose and rationale of the method, a description of the experimental procedure, a critical assessment of the results and their pharmacological and clinical relevance, and pertinent references. Identification of specific tests is facilitated by the enclosed CD-ROM which allows for a quick and full text research. An appendix with guidelines and legal regulations for animal experiments in various countries will help to plan these experiments properly in accordance with the welfare of laboratory animals.

Download or read book Drug Discovery and Evaluation Pharmacological Assays written by Franz J. Hock and published by Springer. This book was released on 2015-11-14 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 4th edition of this successful reference book contains an updated selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Effects covered include cardiovascular, analgesic, endocrine, psychotropic, respiratory, renal and immunomodulatory activities. Each of the more than 1,000 assays comprises a detailed protocol outlining the purpose and rationale of the method, a critical assessment of the results and their pharmacological and clinical relevance. In addition, animal models of rare diseases are described. For this 4th edition, all existing chapters have been revised and completely updated. A large number of assays were added. Sections that have been specifically enlarged include - Pharmacological assays in thrombosis and haemostasis, - Antidiabetic activity (includes completely new chapters such as Biochemical Methods in Diabetology), - Anti-atherosclerotic activity. New chapters are added such as Auditory Pharmacology, Oncology Activity, Stem Cells, Omics, Personalized Medicine, etc.

Download or read book Drug Discovery and Evaluation Pharmacological Assays written by Hans Vogel and published by Springer Science & Business Media. This book was released on 2007-10-30 with total page 2118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new edition of this successful reference offers both cutting-edge and classic pharmacological methods. Thoroughly revised and expanded to two volumes, it offers an updated selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Every chapter has been updated, and numerous assays have been added. Each of the more than 1,000 assays comprises a detailed protocol outlining purpose and rationale, and a critical assessment of the results and their pharmacological and clinical relevance.

Download or read book Drug Discovery and Evaluation Safety and Pharmacokinetic Assays written by H. Gerhard Vogel and published by Springer. This book was released on 2013-02-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: -A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide

Download or read book Drug Discovery and Evaluation Safety and Pharmacokinetic Assays written by H. Gerhard Vogel and published by Springer. This book was released on 2006-09-21 with total page 889 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs. The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process. In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide.

Download or read book Atkinson s Principles of Clinical Pharmacology written by Shiew-Mei Huang and published by Academic Press. This book was released on 2021-10-16 with total page 764 pages. Available in PDF, EPUB and Kindle. Book excerpt: Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK

Download or read book Drug Discovery and Evaluation Safety and Pharmacokinetic Assays written by Franz J. Hock and published by Springer. This book was released on 2024-11-17 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many aspects of drug safety have become an outstanding and even persistent issue and may occur during the process of both drug discovery and development. Until 15 years ago, drug discovery and evaluation was primarily a sequential process starting with the selection of the most pharmacologically active compound from a series of newly synthesized small molecule chemical series by means of distinctive pharmacological assays. Safety aspects were addressed by evaluation of the selected compound at high doses in a series of specific studies directed at indications other than the intended indication of the new compound. These tests are then followed by pharmacokinetic studies, which are primarily conducted to confirm whether the selected compound possesses a suitable half-life for sufficient exposure and efficacy and, whether it has the desired properties specificity to the intended route of administration. Safety aspects relied predominantly on the conduct of single and repeat toxicologydose studies, which inform changes in organ structure rather than organ function. Both toxicological and pharmacokinetic studies are adapted to the progress of studies in clinical pharmacology and clinical trials. The new edition of this well and broadly accepted reference work contains several innovative and distinguished chapters. This "sequential" strategy has been abandoned with this new version of the book for several reasons: - Of the possible multitude of negative effects that novel drugs may impart on organ function, e.g. ventricular tachy-arrhythmia, many are detected too late in non-clinical studies to inform clinicians. On the other hand, negative findings in chronic toxicity studies in animals may turn out to be irrelevant for human beings. - New scientific approaches, e.g. high-throughput screening, human pluripotent stem cells, transgenic animals, knock-out animals, in silico models, pharmaco-genomics and pharmaco-proteomics, as well as Artificial Intelligence (AI) methods offered new possibilities. - There are several examples, that show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed. The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. Research and development scientists, involving the following changes, therefore adopted a change of strategy: - Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization). - The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group and the Safety Pharmacology Society (SPS) was launched. The discipline provided for evaluation, development and validation of a multitude of safety tests outlined in the 'Core Battery of Studies'. - Characterizing the exposure profile of a drug by conducting pharmacokinetic studies that evaluates the absorption, distribution, metabolism and excretion should to be investigated at an early stage of development as results contribute to the selection of a compound for further development. Advancements in Toxicology were achieved by the introduction of new methods, e.g., in silico methods, genetic toxicology, computational toxicology and AI. The book is a landmark in the continuously changing world of drug research and developments. As such, it is essential reading for many groups: not only for all students of pharmacology and toxicology but also for industry scientists and physicians, especially those involved in clinical trials of drugs, and for pharmacists who must know the safety requirements of drugs. The book is essential for scientists and managers in the pharmaceutical industry who are involved in drug discovery, drug development and decision making in the development process. In particular, the book will be of use to government institutions and committees working on official guidelines for drug evaluation worldwide.

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Download or read book Basic Principles of Drug Discovery and Development written by Benjamin E. Blass and published by Academic Press. This book was released on 2021-03-30 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator’s fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist’s early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry

Download or read book Optimization in Drug Discovery written by Gary W. Caldwell and published by Humana. This book was released on 2016-08-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised and updated, Optimization in Drug Discovery: In Vitro Methods, Second Edition presents a wide spectrum of in vitro assays including formulation, plasma binding, absorption and permeability, cytochrome P450 (CYP) and UDP-glucuronosyltransferases (UGT) metabolism, CYP inhibition and induction, drug transporters, drug-drug interactions via assessment of reactive metabolites, genotoxicity, and chemical and photo-mutagenicity assays. Written for the Methods in Pharmacology and Toxicology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Expert authors have developed and utilized these in vitro assays to achieve “drug-like” characteristics in addition to efficacy properties and good safety profiles of drug candidates. Comprehensive and up-to-date, Optimization in Drug Discovery: In Vitro Methods, Second Edition aims to guide researchers down the difficult path to successful drug discovery and development.

Download or read book Animal and Translational Models for CNS Drug Discovery Neurological Disorders written by Robert A. McArthur and published by Academic Press. This book was released on 2008-11-18 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neurological Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for neurological disorders such as neurofibromatosis, Alzheimer’s disease, Parkinson’s disease, Huntington disease, ALS, and the epilepsies. Neurological Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the second volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. Clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasis on what results mean to the overall drug discovery process Exploration of issues in clinical trial design and conductance in each therapeutic area

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Download or read book Drug Discovery Toxicology written by Yvonne Will and published by John Wiley & Sons. This book was released on 2016-03-22 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Download or read book Pharmacometrics written by Ene I. Ette and published by John Wiley & Sons. This book was released on 2013-03-14 with total page 1236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies.

Download or read book Drug Screening Methods written by Suresh Kumar Gupta and published by Anshan Pub. This book was released on 2005 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug discovery and development is a challenging, expensive and time consuming field of research, requiring contributions from chemists, pharmacologists, toxicologists, clinicians, and practitioners. The ultimate goal is to generate a safe and biologically active drug which can stall, or even reverse, the pathological events that cause the disease condition. But in the search for the drug a host of tests and trials must be applied to evaluate the efficiency and safety of the newly developed molecule in the biological system. These trials or "screening methods" are critical. On their basis, the new molecule either becomes accepted for usage, or is discarded forever. Advances in drug research have forced the need for quicker, more automated screening methods, using molecular techniques applied in vitro, in vivo and in clinical systems. Researchers need to know the latest developments outside their own speciality. With this book, Professor Gupta has brought together in one coherent volume the most up to date developments of consolidated screening methods for biological systems. By paying attention to the practical techniques used in academia and the commercial pharmaceutical industry, "Drug Screening Methods" will enjoy a broad readership, serving both the professional community and the student of pharmacology.

Download or read book Chronopharmacology written by Björn Lemmer and published by Marcel Dekker. This book was released on 1989 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chronopharmacology is the study of time-dependent variations in the pharmacokinetics, effects, and side and toxic effects of drugs. After three chapters on basic aspects, the remaining 46 contributions cover various types of drugs and discuss the regulatory issues related to circadian mechanisms and the predictive aspects of the science. Annotation(c) 2003 Book News, Inc., Portland, OR (booknews.com)