Principles of Safety Pharmacology

Principles of Safety Pharmacology PDF Author: Michael K. Pugsley
Publisher: Springer
ISBN: 366246943X
Category : Medical
Languages : en
Pages : 477

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Book Description
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.

Principles of Safety Pharmacology

Principles of Safety Pharmacology PDF Author: Michael K. Pugsley
Publisher: Springer
ISBN: 366246943X
Category : Medical
Languages : en
Pages : 477

Get Book Here

Book Description
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.

Safety Pharmacology in Pharmaceutical Development

Safety Pharmacology in Pharmaceutical Development PDF Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 1439845689
Category : Medical
Languages : en
Pages : 199

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Book Description
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 PDF Author: Shiew-Mei Huang
Publisher: Academic Press
ISBN: 0128198842
Category : Medical
Languages : en
Pages : 764

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Book Description
**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

Basic Principles of Drug Discovery and Development

Basic Principles of Drug Discovery and Development PDF Author: Benjamin E. Blass
Publisher: Academic Press
ISBN: 0128172150
Category : Science
Languages : en
Pages : 738

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Book Description
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

Medical Pharmacology and Therapeutics E-Book

Medical Pharmacology and Therapeutics E-Book PDF Author: Derek G. Waller
Publisher: Elsevier Health Sciences
ISBN: 0702055034
Category : Medical
Languages : en
Pages : 741

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Book Description
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

Principles of Pharmacology

Principles of Pharmacology PDF Author: David E. Golan
Publisher: Lippincott Williams & Wilkins
ISBN: 1608312704
Category : Medical
Languages : en
Pages : 978

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Book Description
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

Principles of Pharmacology

Principles of Pharmacology PDF Author: Susan E. Farrell
Publisher: Lippincott Williams & Wilkins
ISBN: 9780781772082
Category : Medical
Languages : en
Pages : 326

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Book Description
This workbook contains over 100 patient cases and over 400 multiple-choice questions and answers to reinforce the material in Golan's Principles of Pharmacology, Second Edition. All of the cases have been successfully used in teaching pharmacology at Harvard Medical School. Each chapter contains the case from the corresponding chapter in the textbook, plus one or two additional cases. Each case includes multiple-choice questions that require the student to think through the case. Answers and explanations appear at the end of the book. The fully searchable online text is available on thePoint, with a link to the Golan textbook Website.

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays PDF Author: H. Gerhard Vogel
Publisher: Springer
ISBN: 9783642252396
Category : Medical
Languages : en
Pages : 0

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Book Description
-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

Principles of Clinical Pharmacology

Principles of Clinical Pharmacology PDF Author: Arthur J. Atkinson Jr.
Publisher: Elsevier
ISBN: 0080466427
Category : Science
Languages : en
Pages : 567

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Book Description
This revised second edition covers the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development, focusing on the fundamentals that underlie the clinical use and contemporary development of pharmaceuticals. Authors drawn from academia, the pharmaceutical industry and government agencies cover the spectrum of material, including pharmacokinetic practice questions, covered by the basic science section of the certifying examination offered by the American Board of Clinical Pharmacology. This unique reference is recommended by the Board as a study text and includes modules on drug discovery and development to assist students as well as practicing pharmacologists. - Unique breadth of coverage ranging from drug discovery and development to individualization and quality assessment of drug therapy - Unusual cohesive of presentation that stems from author participation in an ongoing popular NIH course - Instructive linkage of pharmacokinetic theory and applications with provision of sample problems for self-study - Wide-ranging perspective of authors drawn from the ranks of Federal agencies, academia and the pharmaceutical industry - Expanded coverage of pharmacogenetics - Expanded coverage of drug transporters and their role in interactions - Inclusion of new material on enzyme induction mechanisms in chapters on drug metabolism and drug interactions - A new chapter on drug discovery that focuses on oncologic agents - Inclusion of therapeutic antibodies in chapter on biotechnology products

Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals PDF Author: Joy A. Cavagnaro
Publisher: John Wiley & Sons
ISBN: 1118679385
Category : Medical
Languages : en
Pages : 1012

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Book Description
"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.