http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
This edition presents a review of the principles and progress surrounding clinical trial simulations (CTS), along with case studies illustrating CTS in various therapeutic and application areas. In addition, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter has been written by esteemed authors who have demonstrated expertise in state-of-the-art application of CTS. The target audience for the volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, regulatory review or guidance of clinical trials, and academic researchers and others working in drug development (e.g., clinicians, senior managers, project planning and regulatory affairs professionals). The focus is on the effective utilization of CTS in decision mechanisms. Readers will gain broad knowledge on how CTS can improve the efficiency, informativeness, speed and economy of model-based drug development and regulation. Holly H.C. Kimko, PhD is a senior pharmacometrics leader (Research Fellow) at the Department of Advanced Modeling & Simulation in Johnson & Johnson Pharmaceutical Research & Development, LLC, New Jersey, and Adjunct Professor in the faculty of the Pharmacy School of Rutgers University, New Jersey. She was previously Assistant Professor in the Center for Drug Development Science in Georgetown University Medical School, Washington DC. Trained in biochemistry and pharmacy, Dr. Kimko earned her Ph.D. degree in Pharmaceutical Science from the State University of New York, Buffalo. She has published key papers on indirect response modeling and applications of CTS, and co-edited Simulation for Designing Clinical Trials. Carl C. Peck, MD is Adjunct Professor, Center for Drug Development Science in the Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco, California. He was previously Director of the FDA Center for Drug Evaluation and Research, Assistant U.S. Surgeon General, and President of the American Society for Clinical Pharmacology and Therapeutics. Dr. Peck has also held professorial appointments in the faculties of UCSF, USUHS, and Georgetown University. He is an author of more than 150 original research papers, chapters and books concerning advanced concepts and techniques of quantitative pharmacology, trial designs, and pharmaco-statistical modeling and simulation.
Clinical Trial Simulation and Quantitative Pharmacology -- Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective -- Contribution of Modeling and Simulation in the Regulatory Review and Decision-Making: U.S FDA Perspective -- Decision-Making in Drug Development: Application of a Model Based Framework for Assessing Trial Performance -- Decision-Making in Drug Development: Application of a Clinical Utility Index -- Adaptive Trial Designs -- Keys of Collaboration to Enhance Efficiency and Impact of Modeling and Simulation -- Leveraging Pharmacometrics in Early Phase Anti-Inflamatory Dug Development -- The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents -- Modeling and Simulation in the Development of Cardiovascular Agents -- Viral Dynamic Modeling and Simulations in HIV and Hepatitis C -- A Model-Based PK/PD Antimicrobial Chemotherapy Drug Development Platform to Simultaneously Combat Infectious Diseases and Drug Resistance -- PKPD and Disease Modeling: Concepts and Applications to Oncology -- Application of Pharmacokinetic-Pharmacodynamic Modeling and Simulation for Erythropoietic Stimulating Agents -- Model Based Development of an Agent for the Treatment of Generalized Anxiety Disorder -- Balancing Efficacy and Safety in the Clinical Development of an Atypical Antipsychotic, Paliperidone Extended-Release -- Application of Modeling and Simulation in the Development of Protein Drugs -- Modeling and Simulation in Pediatric Research and Development -- Disease Progression Analysis: Towards Mechanism-Based Models -- Using a Systems Biology Approach to Explore Hypotheses Underlying Clinical Diversity of the Renin Angiotensin System and the Response to Antihypertensive Therapies -- Recent Developments in Physiologically Based Pharmacokinetic Modeling -- Covariate Distribution Models in Simulation.
edited by Holly H. C. Kimko, Carl C. Peck.
AAPS Advances in the Pharmaceutical Sciences Series, 1