A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
Author: Ali S. Faqi
Publisher: Academic Press
Total Pages: 903
Release: 2012-10-18
Genre: Medical
ISBN: 0123878160
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A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source

Early Drug Development

Early Drug Development
Author: Mitchell N. Cayen
Publisher: John Wiley & Sons
Total Pages: 507
Release: 2011-02-25
Genre: Medical
ISBN: 1118035208
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The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Anticancer Drug Development Guide

Anticancer Drug Development Guide
Author: Beverly A. Teicher
Publisher: Springer Science & Business Media
Total Pages: 514
Release: 2004-02-01
Genre: Medical
ISBN: 1592597394
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This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent. " The recognition following World War I that the administration of toxic chemicals such as nitrogen mustards in a controlled manner could shrink malignant tumor masses for relatively substantial periods of time gave great impetus to the search for molecules that would be lethal to specific cancer cells. Weare still actively engaged in that search today. The question is how to discover these "anticancer" molecules. Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, Second Edition describes the evolution to the present of preclinical screening methods. The National Cancer Institute's high-throughput, in vitro disease-specific screen with 60 or more human tumor cell lines is used to search for molecules with novel mechanisms of action or activity against specific phenotypes. The Human Tumor Colony-Forming Assay (HTCA) uses fresh tumor biopsies as sources of cells that more nearly resemble the human disease. There is no doubt that the greatest successes of traditional chemotherapy have been in the leukemias and lymphomas. Since the earliest widely used in vivo drug screening models were the murine L 1210 and P388 leukemias, the community came to assume that these murine tumor models were appropriate to the discovery of "antileukemia" agents, but that other tumor models would be needed to discover drugs active against solid tumors.

Preclinical Drug Development

Preclinical Drug Development
Author: Mark Rogge
Publisher: CRC Press
Total Pages: 374
Release: 2016-04-19
Genre: Medical
ISBN: 1420084739
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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

Drug Discovery and Development - E-Book

Drug Discovery and Development - E-Book
Author: Raymond G Hill
Publisher: Elsevier Health Sciences
Total Pages: 361
Release: 2012-07-20
Genre: Medical
ISBN: 0702053163
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The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries' trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market. - The definitive introduction to how a pharmaceutical company goes about its business of discovering and developing drugs. The second edition has a new editor: Professor Raymond Hill ● non-executive director of Addex Pharmaceuticals, Covagen and of Orexo AB ● Visiting Industrial Professor of Pharmacology in the University of Bristol ● Visiting Professor in the School of Medical and Health Sciences at the University of Surrey ● Visiting Professor in Physiology and Pharmacology at the University of Strathclyde ● President and Chair of the Council of the British Pharmacological Society ● member of the Nuffield Council on Bioethics and the Advisory Council on Misuse of Drugs. New to this edition: - Completely rewritten chapter on The Role of Medicinal Chemistry in the Drug Discovery Process. - New topic - DMPK Optimization Strategy in drug discovery. - New chapter on Scaffolds: Small globular proteins as antibody substitutes. - Totally updated chapters on Intellectual Property and Marketing - 50 new illustrations in full colour Features - Accessible, general guide to pharmaceutical research and development. - Examines the interfaces between cost and social benefit, quality control and mass production, regulatory bodies, patent management, and all interdisciplinary intersections essential to effective drug development. - Written by a strong team of scientists with long experience in the pharmaceutical industry. - Solid overview of all the steps from lab bench to market in an easy-to-understand way which will be accessible to non-specialists. From customer reviews of the previous edition: '... it will have everything you need to know on this module. Deeply referenced and, thus, deeply reliable. - Highly Commended in the medicine category of the BMA 2006 medical book competition - Winner of the Royal Society of Medicine Library Prize for Medical Book of the Year

Biomarkers in Drug Development

Biomarkers in Drug Development
Author: Michael R. Bleavins
Publisher: John Wiley & Sons
Total Pages: 559
Release: 2011-09-20
Genre: Medical
ISBN: 1118210425
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Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

Fundamentals of Early Clinical Drug Development

Fundamentals of Early Clinical Drug Development
Author: Ahmed F. Abdel-Magid
Publisher: John Wiley & Sons
Total Pages: 341
Release: 2006-09-29
Genre: Science
ISBN: 0470043393
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An informative look at the intricacies of today's drug development process Once a discovery organization has identified a potential new drug candidate, it is the daunting task of synthetic organic chemists to identify the chemical process suitable for preparation of this compound in a highly regulated environment. Only through a multi-layered chemical process that takes into account such factors as safety, environmental considerations, freedom to operate and cost-effectiveness can researchers begin to refine the drug in terms of quality and yield. This book covers both recent advances in the design and synthesis of new drugs, as well as the myriad other issues facing a new drug candidate as it moves through the development process. Utilizing recent case studies, the authors provide valuable insights into the complexities of the process, from designing new synthetic methodologies and applying new automated techniques for finding optimal reaction conditions to selecting the final drug form and formulation. Both novice and active researchers will appreciate the inclusion of chapters on such diverse topics as: * Cross-coupling methods * Asymmetric synthesis * Automation * Chemical Engineering * Application of radioisotopes * Final form selection * Formulations * Intellectual property A wealth of real-world examples and contributions from leading process scientists, engineers, and related professionals make this book a valuable addition to the scientific literature.

Evaluation of Drug Candidates for Preclinical Development

Evaluation of Drug Candidates for Preclinical Development
Author: Chao Han
Publisher: John Wiley & Sons
Total Pages: 306
Release: 2010-01-19
Genre: Medical
ISBN: 0470044918
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Emphasizes the integration of major areas of drug discovery and their importance in candidate evaluation It is believed that selecting the "right" drug candidate for development is the key to success. In the last decade, pharmaceutical R&D departments have integrated pharmacokinetics and drug metabolism, pharmaceutics, and toxicology into early drug discovery to improve the assessment of potential drug compounds. Now, Evaluation of Drug Candidates for Preclinical Development provides a complete view and understanding of why absorption-distribution-metabolism-excretion-toxicology (ADMET) plays a pivotal role in drug discovery and development. Encompassing the three major interrelated areas in which optimization and evaluation of drug developability is most critical—pharmacokinetics and drug metabolism, pharmaceutics, and safety assessment—this unique resource encourages integrated thinking in drug discovery. The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability issues that challenge pharma companies, moving beyond isolated experimental results Reveal connections between the key scientific areas that are critical for successful drug discovery and development Inspire forward-thinking strategies and decision-making processes in preclinical evaluation to maximize the potential of drug candidates to progress through development efficiently and meet the increasing demands of the marketplace Evaluation of Drug Candidates for Preclinical Development serves as an introductory reference for those new to the pharmaceutical industry and drug discovery in particular. It is especially well suited for scientists and management teams in small- to mid-sized pharmaceutical companies, as well as academic researchers and graduate students concerned with the practical aspects related to the evaluation of drug developability.

Drug Discovery, Pre-Clinical and Clinical Drug Development Volume 1

Drug Discovery, Pre-Clinical and Clinical Drug Development Volume 1
Author: Timothy Chinyereugo Ekwebelem
Publisher: Independently Published
Total Pages: 0
Release: 2024-06-16
Genre: Medical
ISBN:
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Drug Discovery, Preclinical, and Clinical Drug Development Volume 1: This is an exceptional book that touches on all aspects of Pharmaceutical and Clinical Research inclusive of drug discovery and preclinical drug development. This book is an all-rounder that covers the scope of the development of medicine and drug research from scratch to finish. This book teaches you all you need to know about drug discovery, the history of drug discovery, preclinical research development, regulatory science, ethics in medicine, and clinical research. This book is exceptional in that it touches on all aspects of drug development with scenario live examples and exercises to help the reader learn how drugs are discovered, screened, synthesized, formulated, pre-clinical, regulatory submission and GCP 2024, Clinical trial preparations, Clinical trial regulatory submission and applications, ethics in clinical research, clinical research design, pharmaceutical medicine, patent laws, and application, etc. This book is a masterpiece for those trying to enter into clinical research and those professionals like clinical research associates, clinical research physicians, clinical research nurses, clinical research students, clinical research coordinators, and clinical trial assistants who might want to have both the theoretical and practical knowledge of clinical research, drug discovery, and development. The book is tagged as an all-rounder in that you got to learn both the background basics and advanced level topics that will increase and broaden your horizon and knowledge in clinical research with a deep understanding of practical aspects of clinical research, preclinical studies, and overall drug discovery/drug development. Those new in the industry about to enter or already old in the industry will find this book practically oriented with a deep understanding of the theoretical aspect of clinical research and development. Some of the topics covered in this are drug discovery, pre-clinical drug development, clinical drug development, medical device trials, ICH-GCP R3 2024 Expectation, Common Technical Document, pharmaceutical medicine, combinatorial chemistry, medicinal chemistry, history of the 21st-century regulatory application and submission guideline 2024, clinical trials and different phases of clinical trials, types of monitoring clinical research and how to monitor clinical research, etc. This is a must-read book that covers all aspects of drug development and clinical drug development from scratch to finish with practical scenario examples, questions and answers, and practice exercises. In this book, you are going to learn the following topics, The History of Drug Discovery, Preclinical Drug Development and Clinical Drug Development. Regulatory Affairs / Ethics in Clinical Research The Role of Regulatory Affairs Professionals US Food and Drug Administration History of 21st-century regulatory/ethical Medical Device Trials Common Technical Documents ICH-GCP R3 2024 Expectation IND applications, methods, and submission Different phases of clinical trials Clinical Research monitoring and types of monitoring. How to design a protocol, case report forms, and recruitment forms How to design clinical research Pharmaceutical Medicine Patenting laws, application, and submission. Clinical Drug Development.

New Drug Development

New Drug Development
Author: J. Rick Turner
Publisher: Springer Science & Business Media
Total Pages: 269
Release: 2010-07-16
Genre: Medical
ISBN: 1441964185
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New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.