Principles of Safety Pharmacology

Principles of Safety Pharmacology
Author: Michael K. Pugsley
Publisher: Springer
Total Pages: 477
Release: 2015-06-19
Genre: Medical
ISBN: 366246943X

This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Early Drug Development, 2 Volume Set

Early Drug Development, 2 Volume Set
Author: Fabrizio Giordanetto
Publisher: John Wiley & Sons
Total Pages: 810
Release: 2018-12-10
Genre: Science
ISBN: 3527341498

This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

Basic Principles of Drug Discovery and Development

Basic Principles of Drug Discovery and Development
Author: Benjamin E. Blass
Publisher: Academic Press
Total Pages: 738
Release: 2021-03-30
Genre: Science
ISBN: 0128172150

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

Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology
Author: Mary Jeanne Kallman
Publisher: Academic Press
Total Pages: 0
Release: 2018-09-07
Genre: Medical
ISBN: 9780128122068

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.

Safety Pharmacology in Pharmaceutical Development

Safety Pharmacology in Pharmaceutical Development
Author: Shayne C. Gad
Publisher: CRC Press
Total Pages: 199
Release: 2012-04-26
Genre: Medical
ISBN: 1439845689

Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Su

Atkinson's Principles of Clinical Pharmacology

Atkinson's Principles of Clinical Pharmacology
Author: Shiew-Mei Huang
Publisher: Academic Press
Total Pages: 764
Release: 2021-10-16
Genre: Medical
ISBN: 0128198842

**Selected for Doody's Core Titles® 2024 in Pharmacology**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

Principles of Pharmacology

Principles of Pharmacology
Author: David E. Golan
Publisher: Lippincott Williams & Wilkins
Total Pages: 978
Release: 2011-12-15
Genre: Medical
ISBN: 1608312704

Now in its third edition, Principles of Pharmacology presents content in a conceptual framework that maximizes understanding and retention and minimizes rote memorization. It takes students "beyond the disease" and deep into physiologic, biochemical, and pathophysiologic systems where drugs activate or inhibit these systems by interacting with molecular and cellular targets. This unique approach ensures understanding of the mechanisms of drug actions on the body, and ultimately, in treating the human patient. Ideal for introductory pharmacology courses that emphasize critical thinking, molecular understanding, systems-based integration, and clinical preparation, the text: Features chapter-opening clinical cases and questions to establish a context for the discussion and the answers that follow Presents signature drug summary tables, updated and organized by mechanism of action, with information on clinical applications, adverse effects, contraindications, and therapeutic considerations Incorporates NEW full-color illustrations throughout, suiting the needs of visual learners and more effectively presenting concepts covered in the narrative Integrates timely content, including recently approved drugs as well as current research on drug mechanisms of action Delivers course and review material appropriate for students through a uniquely collaborative authorship consisting of medical students, residents, and faculty

Stephens' Detection and Evaluation of Adverse Drug Reactions

Stephens' Detection and Evaluation of Adverse Drug Reactions
Author: John Talbot
Publisher: John Wiley & Sons
Total Pages: 751
Release: 2011-10-28
Genre: Medical
ISBN: 1119952107

The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays
Author: H. Gerhard Vogel
Publisher: Springer
Total Pages: 0
Release: 2013-02-27
Genre: Medical
ISBN: 9783642252396

-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

Medical Pharmacology and Therapeutics E-Book

Medical Pharmacology and Therapeutics E-Book
Author: Derek G. Waller
Publisher: Elsevier Health Sciences
Total Pages: 741
Release: 2013-08-07
Genre: Medical
ISBN: 0702055034

This book covers all the pharmacology you need, from basic science pharmacology and pathophysiology, through to clinical pharmacology to therapeutics, in line with the integrated approach of new medical curricula. The first section covers the basic principles, and the rest is organised by body systems. The book ends with sections on toxicity and prescribing practice. Integrates basic science pharmacology, clinical pharmacology and therapeutics Brief review of pathophysiology of major diseases Case histories and multiple choice questions (and answers) Tabular presentation of all common drugs within each class Section on further reading Kinetics chapter simplified with more practical examples Includes more on genetic issues Drug tables made more concise to make information more accessible Fully updated to reflect current clinical practice