Current Topics In Nonclinical Drug Development
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Current Topics In Nonclinical Drug Development
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Author : Pritam S. Sahota
language : en
Publisher: CRC Press
Release Date : 2020-12-22
Current Topics In Nonclinical Drug Development written by Pritam S. Sahota and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-22 with Medical categories.
The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
Current Topics In Nonclinical Drug Development
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Author : Pritam S. Sahota
language : en
Publisher:
Release Date : 2021
Current Topics In Nonclinical Drug Development written by Pritam S. Sahota and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with Drug development categories.
"The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development"--
Current Topics In Nonclinical Drug Development
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Author : Philip Bentley
language : en
Publisher: CRC Press
Release Date : 2023-11-09
Current Topics In Nonclinical Drug Development written by Philip Bentley and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-09 with Science categories.
The second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development. This second volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Select topics include: Evolution of Artificial Intelligence (AI) technologies and the impact on toxicologic pathology. Current approaches to carcinogenicity testing. Predicting drug-drug interactions. Current understanding of idiosyncratic drug reaction. Assessing cardiovascular risks beyond QT interval. Use of 3D cell cultures in toxicology and ADME. Development of small molecule-antibody complexes. Differentiating adverse from non-adverse findings in nonclinical studies. Current Topics in Nonclinical Drug Development: Volume 2 will aid toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists dealing with day-to-day issues encountered in drug development and assist in formulating strategies for resolution of these issues. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
Toxicologic Pathology
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Author : Pritam S. Sahota
language : en
Publisher: CRC Press
Release Date : 2024-03-25
Toxicologic Pathology written by Pritam S. Sahota and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-03-25 with Medical categories.
There has been an enormous growth of interest in the field of toxicologic pathology and particularly on its impact on nonclinical safety assessment in global drug development and in the environment. Toxicologic pathologists play an important role in detecting test article-related adverse effects by characterizing morphologic changes in animal tissues and/or body fluids under prescribed study conditions or less clearly defined conditions in the environment and in the interpretation of these findings relative to human risk. In fact, pathology evaluation is often the single most important decision-making factor in nonclinical safety assessments as 80% of drug candidate attrition has been attributed to pathology findings in toxicity studies. There are currently no primers or basic overviews covering the field of toxicologic pathology, whereas there are at least several basic books that cover the sister field of toxicology. Toxicologic Pathology: A Primer is a practical, easy-to-use reference designed to contain core information provided by board-certified veterinary pathologists, all experts in the field. The Primer contains the basic, underlying principles of toxicologic pathology at the introductory level; thus it will be valuable to the veterinary pathology student who may be considering a career in the field as well as a companion to the seasoned toxicologic pathologist who wants a succinct refresher. The Primer is arranged as chapters presenting each major organ system preceded by an overview chapter covering the field of toxicologic pathology followed by a “concept” chapter describing the role of toxicologic pathology in drug development. Photomicrographs and illustrations provide visual context. The organ system chapters provide histopathologic descriptions of lesions observed in toxicity studies of test articles in drug development and testing of chemicals that may negatively impact the environment. Each organ system chapter provides additional information related to a particular lesion to aid the reader in better understanding its toxicologic significance relative to human risk. Each organ system chapter contains: A brief introduction A succinct description of the anatomy and physiology of the system Descriptions of the most important pathological lesions Differential diagnoses Biological consequences, pathogenesis, and/or mechanism of lesion formation Associated clinical pathology correlates Nonclinical safety scientists such as study directors, non-pathology-oriented contributing scientists such as senior toxicology report reviewers, scientific management of Contract Research Organizations (CROs), and students should find the Primer useful in helping them understand the fundamentals of toxicologic pathology.
Toxicologic Pathology
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Author : Page R. Bouchard
language : en
Publisher: CRC Press
Release Date : 2025-06-23
Toxicologic Pathology written by Page R. Bouchard and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-23 with Medical categories.
The new edition provides practical and timely information for toxicologic pathologists working in drug discovery and development. The introductory concept chapters are consolidated into two more concise and better-organized introductory chapters. The two concept chapters introduce the reader to pharmaceutical R&D, the role of the pathologist in the process, and critical partner scientific disciplines with whom the pathologist will collaborate. In this revision, the organ system chapters incorporate more consistent commentary and guidance on the molecular mechanism of action, human translational relevance, and regulatory impact of pathological findings as they are described in these chapters. Key Features: Aids scientists in understanding spontaneously occurring and compound-related pathological findings Features three new well-respected scientists on the editorial team Includes more consistent commentary and guidance in the organ system chapters
Road To Greatness
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Author : Pritam S. Sahota Donald A. Assmann Mary Arnella-Venezia Michael Rubell Gulzar S. Sandhu Zbigniew W. Wojcinski
language : en
Publisher: Page Publishing Inc
Release Date : 2022-04-08
Road To Greatness written by Pritam S. Sahota Donald A. Assmann Mary Arnella-Venezia Michael Rubell Gulzar S. Sandhu Zbigniew W. Wojcinski and has been published by Page Publishing Inc this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-08 with Self-Help categories.
“Greatness” has been defined as a quality of being great, distinguished, or eminent. “Road to Greatness” employs examples of selected individuals who achieved greatness. The road begins with a desire to become successful by creating a personal path to attain exceptional goals. “Genius= 1% Inspiration and 99% Perspiration.” - Thomas Edison (Inventor: He made 1000 unsuccessful attempts before inventing the light bulb.) “Never, never, never, never give up.” – Sir Winston Churchill (Historian, Nobel Prize Winner in Literature (1953) and Prime Minister of the UK during World War-2.) “A person who never made a mistake never tried anything new.” – Albert Einstein (Theoretical physicist; Winner of the 1921 Nobel Prize in Physics.) “If you can dream it, you can do it.” – Walt Disney (Entrepreneur, animator, writer, film producer; record holder for individual Academy Awards.) “People do not decide to become extraordinary. They decide to accomplish extraordinary things.” Sir Edmund Hillary (Mountaineer, explorer, philanthropist; first climber with Tenzing Norgay to summit Mount Everest in 1953). “Road to Greatness” explores four groupings of over forty success factors that are instrumental in extraordinary achievement: Physical and Mental Fitness Connection of Inner and Outer Circles Constant Learning Skill Development Achieving competence in the success factors enhances an individual’s ability to achieve greatness and can be developed through discipline and deliberate practice by incorporation in small increments into routine activities. True greats consistently grow through self-awareness to overcome their limitations, take on challenges, and endeavor to face the obstacles they encounter. The characteristics and traits that drive greatness are inherent within all of us and can be applied to any field, subject, or discipline. “Road to Greatness” provides a roadmap to create a personalized path to extraordinary achievement for students, parents, teachers and graduates entering the workforce. Although it is uncertain what challenges you will face, the roadmap and exploration of greatness arms you with the tools you will need. As such, only one question remains: Are you willing to embark on your own road to greatness?
Clinical Pharmacology Current Topics And Case Studies
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Author : Markus Müller
language : en
Publisher: Springer
Release Date : 2016-03-15
Clinical Pharmacology Current Topics And Case Studies written by Markus Müller and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-03-15 with Medical categories.
This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry.
A Comprehensive Guide To Toxicology In Nonclinical Drug Development
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Author : Ali S. Faqi
language : en
Publisher: Elsevier
Release Date : 2024-02-11
A Comprehensive Guide To Toxicology In Nonclinical Drug Development written by Ali S. Faqi and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-02-11 with Medical categories.
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy - Includes the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
Drug Discovery And Evaluation Safety And Pharmacokinetic Assays
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Author : Franz J. Hock
language : en
Publisher: Springer Nature
Release Date : 2024-10-21
Drug Discovery And Evaluation Safety And Pharmacokinetic Assays written by Franz J. Hock and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-21 with Medical categories.
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.
Preclinical Drug Development
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Author : Mark Rogge
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Preclinical Drug Development written by Mark Rogge and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: PharmacokineticsModeling and simula