Advanced Issue Resolution in Safety Pharmacology

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Author :
Publisher : Academic Press
ISBN 13 : 0128123346
Total Pages : 360 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Advanced Issue Resolution in Safety Pharmacology by : Mary Jeanne Kallman

Download or read book Advanced Issue Resolution in Safety Pharmacology written by Mary Jeanne Kallman and published by Academic Press. This book was released on 2018-09-05 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. Focuses on pharmacology issues that result during drug development and provides de-risking techniques and practical advice Covers a broad selection of topics, including specialized animal models, PBPK modeling, the use of high frequency EEG in problem-solving, drug-induced self-injury, abuse potential liability, biomarkers, imaging, and much more Focuses on the resolution of these issues in order to better address regulatory expectancies and develop safer, more effective drugs

Principles of Safety Pharmacology

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Author :
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 481 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Hayes' Principles and Methods of Toxicology

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Author :
Publisher : CRC Press
ISBN 13 : 1000875776
Total Pages : 2143 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Hayes' Principles and Methods of Toxicology by : A. Wallace Hayes

Download or read book Hayes' Principles and Methods of Toxicology written by A. Wallace Hayes and published by CRC Press. This book was released on 2023-07-03 with total page 2143 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.

Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 111953030X
Total Pages : 6057 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set by :

Download or read book Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set written by and published by John Wiley & Sons. This book was released on 2021-04-20 with total page 6057 pages. Available in PDF, EPUB and Kindle. Book excerpt: Burger’s Medicinal Chemistry, Drug Discovery and Development Explore the freshly updated flagship reference for medicinal chemists and pharmaceutical professionals The newly revised eighth edition of the eight-volume Burger’s Medicinal Chemistry, Drug Discovery and Development is the latest installment in this celebrated series covering the entirety of the drug development and discovery process. With the addition of expert editors in each subject area, this eight-volume set adds 35 chapters to the extensive existing chapters. New additions include analyses of opioid addiction treatments, antibody and gene therapy for cancer, blood-brain barrier, HIV treatments, and industrial-academic collaboration structures. Along with the incorporation of practical material on drug hunting, the set features sections on drug discovery, drug development, cardiovascular diseases, metabolic diseases, immunology, cancer, anti-Infectives, and CNS disorders. The text continues the legacy of previous volumes in the series by providing recognized, renowned, authoritative, and comprehensive information in the area of drug discovery and development while adding cutting-edge new material on issues like the use of artificial intelligence in medicinal chemistry. Included: Volume 1: Methods in Drug Discovery, edited by Kent D. Stewart Volume 2: Discovering Lead Molecules, edited by Kent D. Stewart Volume 3: Drug Development, edited by Ramnarayan S. Randad and Michael Myers Volume 4: Cardiovascular, Endocrine, and Metabolic Diseases, edited by Scott D. Edmondson Volume 5: Pulmonary, Bone, Immunology, Vitamins, and Autocoid Therapeutic Agents, edited by Bryan H. Norman Volume 6: Cancer, edited by Barry Gold and Donna M. Huryn Volume 7: Anti-Infectives, edited by Roland E. Dolle Volume 8: CNS Disorders, edited by Richard A. Glennon Perfect for research departments in the pharmaceutical and biotechnology industries, Burger’s Medicinal Chemistry, Drug Discovery and Development can be used by graduate students seeking a one-stop reference for drug development and discovery and deserves its place in the libraries of biomedical research institutes, medical, pharmaceutical, and veterinary schools.

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

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Author :
Publisher : World Scientific
ISBN 13 : 9813279168
Total Pages : 524 pages
Book Rating : 4.8/5 (132 download)

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Book Synopsis Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) by : Cobert Barton

Download or read book Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) written by Cobert Barton and published by World Scientific. This book was released on 2019-04-10 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

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Author :
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine

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 118 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.

Stem Cells - From Drug to Drug Discovery

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Author :
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110493764
Total Pages : 232 pages
Book Rating : 4.1/5 (14 download)

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Book Synopsis Stem Cells - From Drug to Drug Discovery by : Khawaja Husnain Haider

Download or read book Stem Cells - From Drug to Drug Discovery written by Khawaja Husnain Haider and published by Walter de Gruyter GmbH & Co KG. This book was released on 2017-03-20 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stem cell based therapy is a 21st century approach of therapeutic intervention which epitomizes a shift from conventional symptomatic treatment strategy to addressing the root cause of the disease process. This is especially a hope for the patients suffering from diseases such as Alzheimer, diabetes, myocardial infarction and other diseases which have always been considered as incurable. Moreover, stem cells provide excellent in vitro disease models for drug development. This book is a compilation of the bench experience of experts from various research labs involved in the cutting edge area of research, describing the use of stem cells both as part of the combinatorial therapeutic intervention approach and as tools (disease model) during drug development.

Advances in Nucleic Acid Therapeutics

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Publisher : Royal Society of Chemistry
ISBN 13 : 1788012097
Total Pages : 566 pages
Book Rating : 4.7/5 (88 download)

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Book Synopsis Advances in Nucleic Acid Therapeutics by : Michael J Gait

Download or read book Advances in Nucleic Acid Therapeutics written by Michael J Gait and published by Royal Society of Chemistry. This book was released on 2019-02-11 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: The sequencing of the human genome and subsequent elucidation of the molecular pathways that are important in the pathology of disease have provided unprecedented opportunities for the development of new therapeutics. Nucleic acid-based drugs have emerged in recent years to yield extremely promising candidates for drug therapy to a wide range of diseases. Advances in Nucleic Acid Therapeutics is a comprehensive review of the latest advances in the field, covering the background of the development of nucleic acids for therapeutic purposes to the array of drug development approaches currently being pursued using antisense, RNAi, aptamer, immune modulatory and other synthetic oligonucleotides. Nucleic acid therapeutics is a field that has been continually innovating to meet the challenges of drug discovery and development; bringing contributions together from leaders at the forefront of progress, this book depicts the many approaches currently being pursued in both academia and industry. A go-to volume for medicinal chemists, Advances in Nucleic Acid Therapeutics provides a broad overview of techniques of contemporary interest in drug discovery.

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

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Author :
Publisher : Springer
ISBN 13 : 9783642252396
Total Pages : 0 pages
Book Rating : 4.2/5 (523 download)

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Book Synopsis Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by : H. Gerhard Vogel

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

Registries for Evaluating Patient Outcomes

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Author :
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

A Pharmacology Primer

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Author :
Publisher : Academic Press
ISBN 13 : 0128139587
Total Pages : 488 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis A Pharmacology Primer by : Terry Kenakin

Download or read book A Pharmacology Primer written by Terry Kenakin and published by Academic Press. This book was released on 2018-10-26 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Pharmacology Primer: Techniques for More Effective and Strategic Drug Discovery, Fifth Edition features the latest ideas and research regarding the application of pharmacology to the process of drug discovery. Written by well-respected pharmacologist, Terry P. Kenakin, this primer is an indispensable resource for all those involved in drug discovery. This updated edition has been thoroughly revised to include material on quantifying drug efficacy through bias and cluster analysis, the impact of molecular dynamics and protein structural analysis, the real time kinetic analysis of drug effect, virtual screening for new drug chemical scaffolds, and much more. With full color illustrations and new examples throughout, this book remains a top reference for all industry and academic scientists that is also ideal for students directly involved in drug discovery or pharmacologic research. Highlights changes surrounding strategies for drug discovery, providing a comprehensive reference and featuring advances in the methods involved Includes multiple new sections, such as development and utilization of models in pharmacology, de-orphanization of new drug targets, predicting impact of disease on drug pharmacokinetics, and the impact of enzyme kinetics on drug-drug interactions Illustrates the application of rapid inexpensive assays to predict activity in the therapeutic setting, showing data outcomes and the limitations inherent in interpreting this data

Evidence-Based Advance and Management of Drug Treatment of Infectious Diseases

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Author :
Publisher : Frontiers Media SA
ISBN 13 : 2889717992
Total Pages : 166 pages
Book Rating : 4.8/5 (897 download)

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Book Synopsis Evidence-Based Advance and Management of Drug Treatment of Infectious Diseases by : Yonggang Zhang

Download or read book Evidence-Based Advance and Management of Drug Treatment of Infectious Diseases written by Yonggang Zhang and published by Frontiers Media SA. This book was released on 2021-12-06 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious diseases are caused by microorganisms that release toxins or invade body tissues. The most common pathogenic organisms are bacteria, viruses, fungi, protozoa, and helminths. Systemic infections usually cause fevers, chills, sweats, malaise, and occasionally headache, muscle and joint pain, or changes in mental status, and even septic shock-MODS. Infectious diseases have always threatened populations and caused great loss of life in history, but since the last century, with the discovery of antibiotics, historical trends have been reversed. It is reported that between 1990 and 2017, age-standardized disability-adjusted life year (DALY) rates decreased by 41.3% (38.8-43.5) for infectious diseases. However, in 2017, lower respiratory infections are still ranked as the third cause of DALYs. Drug therapy is the one of most critical management strategies for infectious diseases. Efficacy and safety of drug therapy should always be considered, especially in elders, neonates and immunosuppressed patients. Off-label drug therapy has been performed for complex infectious diseases, especially for new emerging infectious diseases. However, off-label drug therapy can be extremely complex: some are prone to rational use, while others are more susceptible to the issues of irrational use. With the increasing rate of publication of data in this area, new evidence for the efficacy and safety of different treatment approaches is constantly developing. Thus, rigorous analysis of such data is imperative, which will guide future clinical practice and guidelines.

Pain Management and the Opioid Epidemic

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Author :
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

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Author :
Publisher : Elsevier
ISBN 13 : 0323984622
Total Pages : 1074 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis A Comprehensive Guide to Toxicology in Nonclinical Drug Development by : Ali S. Faqi

Download or read book A Comprehensive Guide to Toxicology in Nonclinical Drug Development written by Ali S. Faqi and published by Elsevier. This book was released on 2024-02-11 with total page 1074 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Urologic Pharmacology, An Issue of Urologic Clinics, E-Book

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 032384927X
Total Pages : 227 pages
Book Rating : 4.3/5 (238 download)

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Book Synopsis Urologic Pharmacology, An Issue of Urologic Clinics, E-Book by : Craig V. Comiter

Download or read book Urologic Pharmacology, An Issue of Urologic Clinics, E-Book written by Craig V. Comiter and published by Elsevier Health Sciences. This book was released on 2022-04-16 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this issue of Urologic Clinics of North America, guest editor Dr. Craig V. Comiter brings his considerable expertise to the topic of Urologic Pharmacology. Medical therapies for benign prostatic hyperplasia, erectile dysfunction, hypogonadism, overactive bladder, and prostate cancer are widely available, and a basic understanding of the pharmacology of existing treatment options are necessary to avoid complications and maximize efficacy associated with patient outcomes. In this issue, top experts in the field provide current clinical information to help urologists effectively and quickly treat patients. Contains 14 relevant, practice-oriented topics including medical treatment for benign prostatic hyperplasia, medical treatment for urinary tract infections, nutraceuticals and phytotherapy in men’s health, hormonal therapy for prostate cancer, medical treatment of female sexual dysfunction, and more. Provides in-depth clinical reviews on urologic pharmacology, offering actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews.

Concepts and Principles of Pharmacology

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Author :
Publisher : Springer Nature
ISBN 13 : 3030353621
Total Pages : 466 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Concepts and Principles of Pharmacology by : James E. Barrett

Download or read book Concepts and Principles of Pharmacology written by James E. Barrett and published by Springer Nature. This book was released on 2019-12-24 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Celebrating 100 years of HEP, this volume will discuss key pharmacological discoveries and concepts of the past 100 years. These discoveries have dramatically changed the medical treatment paradigms of many diseases and these concepts have and will continue to shape discovery of new medicinies. Newly evolving technologies will similarly be discussed as they will shape the future of the pharmacology and, accordingly, medical therapy.

The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder

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Author :
Publisher : American Psychiatric Pub
ISBN 13 : 0890426821
Total Pages : 226 pages
Book Rating : 4.8/5 (94 download)

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Book Synopsis The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder by : American Psychiatric Association

Download or read book The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder written by American Psychiatric Association and published by American Psychiatric Pub. This book was released on 2018-01-11 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: The guideline focuses specifically on evidence-based pharmacological treatments for AUD in outpatient settings and includes additional information on assessment and treatment planning, which are an integral part of using pharmacotherapy to treat AUD.