Main 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

Contents:

Molecular Targets

Annunziata, Christina M. (et al.)

Preclinical Screening for New Anticancer Agents

Burger, Angelika M. (et al.)

Natural Product Screening

McKee, Tawnya C. (et al.)

Defining the Starting Dose: Should It Be mg/kg, mg/m

Gao, Bo (et al.)

Phase 0 Trials in Oncology

Kummar, Shivaani (et al.)

Phase I Trials in Oncology: Design and Endpoints

Glen, Hilary (et al.)

Quantitative Analytical Methods: Development and Clinical Considerations

Gardner, Erin R.

Validation and Control of Bioanalytical Methods

Karnes, H. Thomas (et al.)

Anticancer Clinical Pharmacology Overview

Dandamudi, Uday B. (et al.)

Pharmacokinetic Modeling

Li, Jing (et al.)

Pharmacometrics

Brar, Satjit S. (et al.)

Pharmacodynamic Modeling

Bauer, Kenneth S. (et al.)

Protein Binding

Sparreboom, Alex (et al.)

Metabolism (Non-CYP Enzymes)

Jamieson, David (et al.)

Pharmacogenomics and Cancer Therapy: Somatic and Germline Polymorphisms

Patel, Jai N. (et al.)

Cytochrome P450

Ando, Yuichi

Polymorphisms in Genes of Drug Targets and Metabolism

Bohanes, Pierre (et al.)

DNA Repair: ERCC1, Nucleotide Excision Repair, and Platinum Resistance

Reed, Eddie (et al.)

Drug Interactions

Rivory, Laurent P.

ABC Transporters: Involvement in Multidrug Resistance and Drug Disposition

Massey, Paul R. (et al.)

Solute Carriers

Ho, Richard H. (et al.)

High-Throughput Platforms in Drug Metabolism and Transport Pharmacogenetics

English, Bevin C. (et al.)

Intrathecal Administration

Kilburn, Lindsay B. (et al.)

Microdialysis

Combest, Austin J. (et al.)

Regional Drug Delivery for Inoperable Pulmonary Malignancies

Schrump, David S.

Blood-Brain Barrier and CNS Malignancy

Balmanoukian, Ani (et al.)

Radiation and Altering Clinical Pharmacology

Smart, DeeDee (et al.)

Therapeutic Cancer Vaccines: An Emerging Approach to Cancer Treatment

Madan, Ravi A. (et al.)
Recombinant Immunotoxins

Kreitman, Robert J.

Monoclonal Antibodies

Bai, Shuang (et al.)

Clinical Pharmacology in Pediatrics

Tagen, Michael (et al.)

Clinical Pharmacology in the Older Adult

Slattum, Patricia W. (et al.)

Organ Dysfunction Trials: Background, Historical Barriers, Progress in Overcoming Barriers, and Suggestions for Future Trials

Kummar, Shivaani (et al.)

Drug Formulations: How these Affects Anticancer Drug

Lagas, Jurjen S. (et al.)

Nanotechnology in Cancer

Janat-Amsbury, Margit M. (et al.)

Imaging in Drug Development

Kurdziel, Karen A. (et al.)

Exposure-Response Relationships of Anticancer Agents: Application in Drug Development and Drug Label

Rahman, Atiqur

The Role of Phase III Trials in Modern Drug Development

Murphy, Janet E. (et al.)

Clinical Trial Designs for Approval of New Anticancer Agents

Chadha, Manpreet K. (et al.)

Clinical Pharmacogenetics

Sachidanandam, Kamakshi (et al.)