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Author: Michelle A. Rudek
Publisher: Springer Science & Business Media
ISBN: 1461491355
Category : Medical
Languages : en
Pages : 828
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Book Description
There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer. Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs. Road map to anticancer drug development from discovery to NDA submission Discussion of molecular targets and preclinical screening Development and validation of bioanalytical methods Chapters on clinical trial design and phase 0, I, II, III clinical trials Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents Review of the drug development process from both laboratory and clinical perspectives New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development
Author: Michelle A. Rudek
Publisher: Springer Science & Business Media
ISBN: 1461491355
Category : Medical
Languages : en
Pages : 828
Get Book Here
Book Description
There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer. Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs. Road map to anticancer drug development from discovery to NDA submission Discussion of molecular targets and preclinical screening Development and validation of bioanalytical methods Chapters on clinical trial design and phase 0, I, II, III clinical trials Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents Review of the drug development process from both laboratory and clinical perspectives New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development
Author: Louise B. Grochow
Publisher: Lippincott Williams & Wilkins
ISBN:
Category : Medical
Languages : en
Pages : 612
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Book Description
Author: Ashkan Emadi, MD, PhD
Publisher: Springer Publishing Company
ISBN: 0826149332
Category : Medical
Languages : en
Pages : 471
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Book Description
Cancer Pharmacology: An Illustrated Manual of Anticancer Drugs, Second Edition is a visually engaging reference detailing the essential basic and clinical science of all approved, effective, and life-prolonging drug therapies in oncology. Now with a greater emphasis on clinical context, application, and management in each chapter, this significantly revised edition provides both early-career and seasoned clinicians with a practical, bench-to-bedside approach and patient-oriented guide. The book provides detailed coverage of the major advances in cancer pharmacology at the forefront of our standards of care for solid tumors and hematologic malignancies, in addition to the basic science that is directly necessary and applicable when at the patient’s bedside. Everything from traditional cytotoxic agents to targeted genomic, epigenomic, hormonal, and immunotherapeutic agents is explored, in addition to a new chapter covering pharmacogenomics. Accompanied by elegant illustrations, each chapter details the tumor microenvironment, chemical structures of agents, pharmacodynamics, pharmacokinetics, pharmacogenomic and molecular properties of the various agents, and their mechanisms of action. The book covers alkylating agents, antimetabolites, antimitotics, epigenetic modulators, hormonal agents, targeted therapies, monoclonal antibodies, immunotherapeutic agents, and much more. Thoroughly updated to include new FDA-approved treatments and applications, and written by leading experts in cancer pharmacology, this second edition continues to be a “must have” for anyone involved in the basic, translational, or clinical aspects of oncology and hematology, including clinicians, pharmacists, nurses, and trainees. Key Features: Over 150 beautiful illustrations depict structures, pharmacokinetics, pharmacodynamics, and pharmacogenomics associated with each class of agents Contains more than 160 high-yield hematology and oncology board-style chapter review questions (more than double the previous edition) with descriptive rationales Describes how chemotherapy, targeted therapy, immunotherapy, and hormonal therapy work, and why they are expected to work adjuvantly, neoadjuvantly, and in combination with other treatment modalities Thoroughly updated and revised chapters cover new FDA drug approvals, disease-site indications, clinical applications and management of drug-to-drug interactions, and toxicities Discusses challenges related to drug development, drug approval, and regulatory issues in relation to anticancer treatments Provides important pharmacotherapy context with clinical pearls in each chapter that help support a patient-oriented, bedside approach
Author: Mehdi Boroujerdi
Publisher: CRC Press
ISBN: 1000878473
Category : Medical
Languages : en
Pages : 905
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Book Description
This fully revised and expanded volume is an effort to blend the common approaches to pharmacokinetics and toxicokinetics. It integrates the principles held in common by both fields through a logical and systematic approach, which includes mathematical descriptions of physical and physiological processes employed in the approaches to pharmacokinetics and toxicokinetics modeling. It emphasizes general principles and concepts and related, isolated applications and case study observations. The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research, scientific or regulatory decisions, or for offering advanced courses/workshops and seminars. Features: Comprehensive handbook on principles and applications of PK/TK appealing to a diverse audience including scientists and students An excellent text fully revised and fully updated for anyone interested in the theoretical and practical pharmacokinetics The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research Incorporates research relevant to SDGs and of interest to industrial and regulatory environmental scientists involved in chemical contamination research and regulatory decision making related to soil, water, and ocean Includes sections on applications and case studies
Author: William Figg
Publisher: Humana Press
ISBN: 9781588291776
Category : Medical
Languages : en
Pages : 623
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Book Description
Leading investigators synthesize the entire laboratory and clinical process of developing anticancer drugs to create a single indispensable reference that covers all the steps from the identification of cancer-specific targets to phase III clinical trials. These expert authors provide their best guidance on a wide variety of issues, including clinical trial design, preclinical screening, and the development and validation of bioanalytic methods. The chapters on identifying agents to test in phase III trials and on trial design for the approval of new anticancer agents offer a unique roadmap for moving an agent to NDA submission.
Author: William D. Figg
Publisher: Springer Science & Business Media
ISBN: 1592597343
Category : Medical
Languages : en
Pages : 623
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Book Description
Leading investigators synthesize the entire laboratory and clinical process of developing anticancer drugs to create a single indispensable reference that covers all the steps from the identification of cancer-specific targets to phase III clinical trials. These expert authors provide their best guidance on a wide variety of issues, including clinical trial design, preclinical screening, and the development and validation of bioanalytic methods. The chapters on identifying agents to test in phase III trials and on trial design for the approval of new anticancer agents offer a unique roadmap for moving an agent to NDA submission.
Author: Daniel Budman
Publisher: Lippincott Raven
ISBN: 9780781740104
Category : Medical
Languages : en
Pages : 502
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Book Description
Perhaps no area of pharmacology has progressed further or faster than that of anticancer drugs. With this concise and informative resource, you'll explore the full spectrum of anticancer drug evolution -- from research and development, through clinical trials, to licensure and utilization.
Author: Beverly A. Teicher
Publisher: Springer Science & Business Media
ISBN: 1461581524
Category : Medical
Languages : en
Pages : 315
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Book Description
Experienced cancer researchers from pharmaceutical companies, government laboratories, and academia comprehensively review and describe the arduous process of cancer drug discovery and approval. They focus on using preclinical in vivo and in vitro methods to identify molecules of interest, detailing the targets and criteria for success in each type of testing and defining the value of the information obtained from the various tests. They also define each stage of clinical testing, explain the criteria for success, and outline the requirements for FDA approval. A companion volume by the same editor (Cancer Therapeutics: Experimental and Clinical Agents) reviews existing anticancer drugs and potential anticancer therapies. These two volumes in the Cancer Drug Discovery and Development series reveal how and why molecules become anticancer drugs and thus offer a blueprint for the present and the future of the field.
Author: Peter L. Bonate
Publisher: Springer
ISBN: 3319390538
Category : Medical
Languages : en
Pages : 336
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Book Description
In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely – to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist’s point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.
Author: Younggil Kwon
Publisher: Springer Science & Business Media
ISBN: 0306468204
Category : Medical
Languages : en
Pages : 302
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Book Description
In the pharmaceutical industry, the incorporation of the disciplines of pharma- kinetics, pharmacodynamics, and drug metabolism (PK/PD/DM) into various drug development processes has been recognized to be extremely important for approp- ate compound selection and optimization. During discovery phases, the identifi- tion of the critical PK/PD/DM issues of new compounds plays an essential role in understanding their pharmacological profiles and structure-activity relationships. Owing to recent progress in analytical chemistry, a large number of compounds can be screened for their PK/PD/DM properties within a relatively short period of time. During development phases as well, the toxicology and clinical study designs and trials of a compound should be based on a thorough understanding of its PK/PD/DM properties. During my time as an industrial scientist, I realized that a reference work designed for practical industrial applications of PK/PD/DM could be a very valuable tool for researchers not only in the pharmacokinetics and drug metabolism departments, but also for other discovery and development groups in pharmaceutical companies. This book is designed specifically for industrial scientists, laboratory assistants, and managers who are involved in PK/PD/DM-related areas. It consists of thirteen chapters, each of which deals with a particular PK/PD/DM issue and its industrial applications. Chapters 3 and 12 in particular address recent topics on higher throughput in vivo exposure screening and the prediction of pharmacokinetics in humans, respectively. Chapter 8 covers essential information on drug metabolism for industrial scientists.
