Anticancer Drug Development Guide

This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent.

Anticancer Drug Development Guide

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.

Principles of Anticancer Drug Development

A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs. A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.

Principles of Anticancer Drug Development

A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.

Anticancer Drug Development Guide

This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent.

Anticancer Drug Development Guide

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.

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

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 ...

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

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

Anticancer Drug Development Guide

Since additional drugs exhibited some anticancer From: Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval Edited by: B. Teicher Humana Press Inc., Totowa, NJ activity and the supply of new candidate ...

Anticancer Drug Development Guide

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.

Anticancer Drug Development

In “Anticancer Drug Development Guide” (B. A. Teicher, ed.), pp. 59–74. Humana Press, Totowa, NJ. Wechter, W. J., Leipold, D. D., Murray, E. D. Jr, Quiggle, D., McCracken, J. D., Barrios, R. S., and Greenberg, N. M. (2000).

Anticancer Drug Development

Here in a single source is a complete spectrum of ideas on the development of new anticancer drugs. Containing concise reviews of multidisciplinary fields of research, this book offers a wealth of ideas on current and future molecular targets for drug design, including signal transduction, the cell division cycle, and programmed cell death. Detailed descriptions of sources for new drugs and methods for testing and clinical trial design are also provided. One work that can be consulted for all aspects of anticancer drug development Concise reviews of research fields, combined with practical scientific detail, written by internationally respected experts A wealth of ideas on current and future molecular targets for drug design, including signal transduction, the cell division cycle, and programmed cell death Detailed descriptions of the sources of new anticancer drugs, including combinatorial chemistry, phage display, and natural products Discussion of how new drugs can be tested in preclinical systems, including the latest technology of robotic assay systems, cell culture, and experimental animal techniques Hundreds of references that allow the reader to access relevant scientific and medical literature Clear illustrations, some in color, that provide both understanding of the field and material for teaching

Tumor Models in Cancer Research

Anticancer drug development guide: preclinical screening, clinical trials, and approval. 2nd ed. 2004. Humana press, Totowa, NJ. Skipper HE, Schabel FM Jr, Wilcox WS. Experimental evaluation of potential anticancer agents. XIII.

Tumor Models in Cancer Research

The past 6 years since the first edition of this book have seen great progress in the development of genetically engineered mouse (GEM) models of cancer. These models are finding an important role in furthering our understanding of the biology of malignant disease. A comfortable position for GEM models in the routine conduct of screening for potential new therapeutics is coming more slowly but is coming. Increasing numbers of genetically engineered mice are available, some with conditional activation of oncogenes, some with multiple genetic changes providing mouse models that are moving closer to the human disease.

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

Plowman J, Dykes D, Hollingshead M, Simpson-Herren L, Alley M. Human tumor xenografts in NCI drug development. In: Teicher BA (ed). Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval.

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

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.

Cancer Therapeutics

This comprehensive review of existing and potential anticancer drugs and therapies by leading researchers from academia, government laboratories, and pharmaceutical companies offers essential insight into what has been accomplished and ...

Cancer Therapeutics

This comprehensive review of existing and potential anticancer drugs and therapies by leading researchers from academia, government laboratories, and pharmaceutical companies offers essential insight into what has been accomplished and where the experimental therapy of cancer is going. The authoritative contributors illuminate the current status of the major molecules of cancer treatment, ranging from the nitrogen mustards through platinum complexes to interferons, cytokines, growth factors and their inhibitors, and on to immunotoxins, antisense oligonucleotides, and gene therapy. A companion volume by the same editor (Anticancer Drug Development Guide: Preclinical and Clinical Screening and Approval) details the processes by which new anticancer drugs are approved. 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.

In Vitro Bioassay Techniques for Anticancer Drug Discovery and Development

R. H. Shoemaker, The NCI60 human tumour cell line anticancer drug screen, Nature Reviews Cancer, 6, 813–823, 2006. 19. B. Teicher, Anticancer Drug Development Guide. Humana Press, New Jersey, 1997. 20. M. G. Hollingshead, M. C. Alley, ...

In Vitro Bioassay Techniques for Anticancer Drug Discovery and Development

This comprehensive and useful handbook represents a definitive up-to-date compendium of key in vitro bioassay methods that are employed to quantify and validate the anticancer activity of a drug candidate before it makes its way in to animal or clinical trials. In Vitro Bioassay Techniques for Anticancer Drug Discovery and Development covers the screening and evaluation of potential drug candidates in a wide category of anticancer assays demonstrating the specific ways in which various pharmaceutical bioassays interpret the activity of drug molecules. The major emphasis of the book is to present those bioassays which can be readily set up and practiced in any laboratory with limited funds, facilities or technical know-how.

New Approaches to Natural Anticancer Drugs

This book provides an up-to-date review of recently identified natural anti-tumor compounds from various natural origins including plants, fungi, endophytic fungi and marine organisms.

New Approaches to Natural Anticancer Drugs

This book provides an up-to-date review of recently identified natural anti-tumor compounds from various natural origins including plants, fungi, endophytic fungi and marine organisms. It also includes discussion of new areas such as biotechnology and nanoparticles. Chapters explain the challenges and developments in anti-cancer drug discovery approaches, traditional remedies for prevention and treatment of cancer, marine-derived anti-cancer compounds, and antibiotics used as anti-cancer agents, as well as different classes of terpenoids and carbohydrates, which have been the subject of discussion in this field as efficient anti-cancer candidates. This book will be a concise guide for researchers in the field of pharmaceutical sciences, students and residents in pharmacy and medicine as well as those researching phytochemistry and natural products.

In Vitro Bioassay Techniques for Anticancer Drug Discovery and Development

Key Features, Provides a user-friendly, one-stop, comprehensive and coherent foundation for in vitro anticancer drug development, An essential guide to young investigators starting a program on natural resources in the anticancer area from ...

In Vitro Bioassay Techniques for Anticancer Drug Discovery and Development

This comprehensive and useful handbook represents a definitive up-to-date compendium of key in vitro bioassay methods that are employed to quantify and validate the anticancer activity of a drug candidate before it makes its way in to animal or clinical trials. In Vitro Bioassay Techniques for Anticancer Drug Discovery and Development covers the screening and evaluation of potential drug candidates in a wide category of anticancer assays demonstrating the specific ways in which various pharmaceutical bioassays interpret the activity of drug molecules. The major emphasis of the book is to present those bioassays which can be readily set up and practiced in any laboratory with limited funds, facilities or technical know-how.

Phase I Oncology Drug Development

This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials.

Phase I Oncology Drug Development

This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.

Principles of Clinical Pharmacology

Fertile seed and rich soil: The development of clinically relevant models of human cancer by surgical orthotopic implantation of intact tissue. In: Teicher BA, editor. Anticancer drug development guide: Preclinical screening, ...

Principles of Clinical Pharmacology

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

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nature Review Drug Discovery 2004;3:711e5. Arrondeau J, Gan HK, Razak ARA, Paoletti X, Le Tourneau C. Development of anti-cancer drugs. Discovery Medicine 2010 ...

A Comprehensive Guide to Toxicology in Preclinical Drug Development

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

Cancer Pharmacology

From traditional cytotoxic agents to targeted genomic, epigenomic, hormonal, and immunotherapeutic agents, this book covers the staggering advances in cancer pharmacology that are propelling new standards of care for common and uncommon ...

Cancer Pharmacology

Cancer Pharmacology: An Illustrated Manual of Anticancer Drugs provides a one-stop guide to the essential basic and clinical science of all the effective, life-prolonging drug therapies in oncology. From traditional cytotoxic agents to targeted genomic, epigenomic, hormonal, and immunotherapeutic agents, this book covers the staggering advances in cancer pharmacology that are propelling new standards of care for common and uncommon malignancies. Beautifully illustrated throughout, each chapter contains visually engaging figures detailing the tumor microenvironment, chemical structures of agents, pharmacodynamics, pharmacokinetics, pharmacogenomic, and molecular properties of the various agents, and their mechanisms of action. As the first illustrated book of its kind, this highly visual text uses a uniform approach to each cancer drug class and agent presented in the book, and covers alkylating agents, antimetabolites, antimitotics, epigenetic modulators, hormonal agents, targeted therapies, monoclonal antibodies, immunotherapeutic agents, and much more. Flow diagrams, clinical tables, and bulleted text further explain important information pertaining to each cancer drug class including their indications, mechanisms of action, potential adverse reactions, dosing and dose adjustments, and safety monitoring. Organized in an easyto- digest format and replete with detailed images, clinical pearls, and end of chapter Q&As, this evidence-based reference presents all major classes, agents, targets, and approaches to cancer pharmacotherapy. Whether you are a trainee, a clinical scientist, or a clinician in practice, the book is an ideal reference. It presents challenging information in an instructional way, illustrates key concepts for ease of retention, and poses tough questions so readers can problem solve potential scenarios and test their pharmacologic acumen. Written by leading experts in oncopharmacology, this first-of-its kind manual is 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: In Includes visual depictions of chemical structures, pharmacokinetics, pharmacodynamics, and pharmacogenomics associated with each class of agents Describes how chemotherapy, targeted therapy, immunotherapy, and hormonal therapy work and why they are expected to work adjuvantly, neoadjuvantly, and in combination with other modalities Over 100 highly stylized images and numerous comprehensive tables Covers challenges related to drug development, drug approval, and regulatory issues in relation to anticancer treatments All chapters conclude with clinical pearls and detailed clinical Q&As with descriptive rationales Purchase includes access to the ebook for use on most mobile devices or computers

Collaborative Innovation in Drug Discovery

Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval. Totowa, NJ: Humana Press; 1997, p.59. 5. Takimoto, C.H. Anticancer drug development at the US National Cancer Institute. Cancer Chemother Pharmacol ...

Collaborative Innovation in Drug Discovery

Can academia save the pharmaceutical industry? The pharmaceutical industry is at a crossroads. The urgent needfor novel therapies cannot stem the skyrocketing costs andplummeting productivity plaguing R&D, and many key products arefacing patent expiration. Dr. Rathnam Chaguturu presents a case forcollaboration between the pharmaceutical industry and academia thatcould reverse the industry's decline. CollaborativeInnovation in Drug Discovery: Strategies for Public and PrivatePartnerships provides insight into the potential synergyof basing R&D in academia while leaving drug companies to turnhits into marketable products. As Founder and CEO ofiDDPartners, focused on pharmaceutical innovation, Foundingpresident of the International Chemical Biology Society, and SeniorDirector-Discovery Sciences, SRI International, Dr. Chaguturu hasassembled a panel of experts from around the world to weigh in onissues that affect the two driving forces in medicaladvancement. Gain global perspectives on the benefits and potential issuessurrounding collaborative innovation Discover how industries can come together to prevent another"Pharma Cliff" Learn how nonprofits are becoming the driving force behindinnovation Read case studies of specific academia-pharma partnerships forreal-life examples of successful collaboration Explore government initiatives that help foster cooperationbetween industry and academia Dr. Chaguturu’s thirty-five years of experience inacademia and industry, managing new lead discovery projects andforging collaborative partnerships with academia, diseasefoundations, nonprofits, and government agencies lend him aninformative perspective into the issues facing pharmaceuticalprogress. In Collaborative Innovation in Drug Discovery:Strategies for Public and Private Partnerships, he and hisexpert team provide insight into the various nuances of thedebate.

Topics in Anti Cancer Research Volume 10

Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS Biol 2010; 8(6)e1000412 ... In: Teicher BA, Andrews PA, Eds. Anticancer Drug Development Guide. Totowa, NJ: Humana Press 2004; pp.

Topics in Anti Cancer Research  Volume 10

Topics in Anti-Cancer Research covers new developments in the field of cancer diagnosis and drug therapy. Novel drugs as anticancer agents include natural and synthetic phenazirines and other anti-cancer compounds. The series also covers information on the current understanding of the pathology and molecular biology of specific neoplasms. The diversity of research topics published in this book series give broad and valuable perspectives for cancer researchers, clinicians, cancer professionals aiming to develop novel anti-cancer targets and patents for the treatment of various cancers. The topics covered in this volume are: - Peptides can play a major role in combating cancer diseases - Studying of the CLL after treatment using fractal parameter of neoplastic lymphocytes detection (ΛNLD) - Mechanistic insight of rhenium-based compounds as anti- cancer agents - Targeting cancer-specific inflammatory components in cancer therapeutics - Marine natural products as a source of novel anticancer agents: a treasure from the ocean - PDX clinical trial design in anti-cancer research

Anticancer Research

Features : Summarizes the fundamental causes of cancer , modes of treatment , and the philosophy of cancer drug discovery ; Brings together a broad spectrum of information relating to the chemistry and pharmacology of anticancer drugs ...

Anticancer Research