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.

These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. They fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection. Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry.

How do you analyze pretest-posttest data? Difference scores? Percent change scores? ANOVA? In medical, psychological, sociological, and educational studies, researchers often design experiments in which they collect baseline (pretest) data prior to randomization. However, they often find it difficult to decide which method of statistical analysis is most appropriate to use. Until now, consulting the available literature would prove a long and arduous task, with papers sparsely scattered throughout journals and textbook references few and far between. Analysis of Pretest-Posttest Designs brings welcome relief from this conundrum. This one-stop reference - written specifically for researchers - answers the questions and helps clear the confusion about analyzing pretest-posttest data. Keeping derivations to a minimum and offering real life examples from a range of disciplines, the author gathers and elucidates the concepts and techniques most useful for studies incorporating baseline data. Understand the pros and cons of different methods - ANOVA, ANCOVA, percent change, difference scores, and more Learn to choose the most appropriate statistical test - Numerous Monte Carlo simulations compare the various tests and help you select the one best suited to your data Tackle more difficult analyses - The extensive SAS code included saves you programming time and effort Requiring just a basic background in statistics and experimental design, this book incorporates most, if not all of the reference material that deals with pretest-posttest data. If you use baseline data in your studies, Analysis of Pretest-Posttest Designs will save you time, increase your understanding, and ultimately improve the interpretation and analysis of your data.

How do you analyze pretest-posttest data? Difference scores? Percent change scores? ANOVA? In medical, psychological, sociological, and educational studies, researchers often design experiments in which they collect baseline (pretest) data prior to randomization. However, they often find it difficult to decide which method of statistical analysis is most appropriate to use. Until now, consulting the available literature would prove a long and arduous task, with papers sparsely scattered throughout journals and textbook references few and far between.

Analysis of Pretest-Posttest Designs brings welcome relief from this conundrum. This one-stop reference - written specifically for researchers - answers the questions and helps clear the confusion about analyzing pretest-posttest data. Keeping derivations to a minimum and offering real life examples from a range of disciplines, the author gathers and elucidates the concepts and techniques most useful for studies incorporating baseline data.

Understand the pros and cons of different methods - ANOVA, ANCOVA, percent change, difference scores, and more

Learn to choose the most appropriate statistical test - Numerous Monte Carlo simulations compare the various tests and help you select the one best suited to your data

Tackle more difficult analyses - The extensive SAS code included saves you programming time and effort

Requiring just a basic background in statistics and experimental design, this book incorporates most, if not all of the reference material that deals with pretest-posttest data. If you use baseline data in your studies, Analysis of Pretest-Posttest Designs will save you time, increase your understanding, and ultimately improve the interpretation and analysis of your data.

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.

The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection. Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry.

This is a second edition to the original published by Springer in 2006. The comprehensive volume takes a textbook approach systematically developing the field by starting from linear models and then moving up to generalized linear and non-linear mixed effects models. Since the first edition was published the field has grown considerably in terms of maturity and technicality. The second edition of the book therefore considerably expands with the addition of three new chapters relating to Bayesian models, Generalized linear and nonlinear mixed effects models, and Principles of simulation. In addition, many of the other chapters have been expanded and updated.