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Dose Finding in Drug Development
  • Language: en
  • Pages: 262

Dose Finding in Drug Development

If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.

Clinical Trials in Neurology
  • Language: en
  • Pages: 387

Clinical Trials in Neurology

Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences.

Simulation for Designing Clinical Trials
  • Language: en
  • Pages: 416

Simulation for Designing Clinical Trials

  • Type: Book
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  • Published: 2002-12-12
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  • Publisher: CRC Press

Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation p

Pharmacometrics
  • Language: en
  • Pages: 1236

Pharmacometrics

Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies.

Modeling and Using Context
  • Language: en
  • Pages: 1392

Modeling and Using Context

This book constitutes the refereed proceedings of the 5th International and Interdisciplinary Conference on Modeling and Using Context, CONTEXT 2005, held in Paris, France in July 2005. The 42 revised full papers presented were carefully reviewed and selected from a total of 120 submissions. The papers presented deal with the interdisciplinary topic of modeling and using context from various points of view, ranging through cognitive science, formal logic, artifical intelligence, computational intelligence, philosophical and psychological aspects, and information processing. Highly general philosophical and theoretical issues are complemented by specific applications in various fields.

Principles of Clinical Pharmacology
  • Language: en
  • Pages: 567

Principles of Clinical Pharmacology

  • Type: Book
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  • Published: 2011-04-28
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  • Publisher: Elsevier

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 practic...

Generics and Bioequivalence
  • Language: en
  • Pages: 216

Generics and Bioequivalence

  • Type: Book
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  • Published: 2019-06-13
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  • Publisher: CRC Press

Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.

Essentials of Translational Pediatric Drug Development
  • Language: en
  • Pages: 732

Essentials of Translational Pediatric Drug Development

  • Type: Book
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  • Published: 2024-07-23
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  • Publisher: Elsevier

Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consens...

Paediatric Clinical Pharmacology
  • Language: en
  • Pages: 830

Paediatric Clinical Pharmacology

  • Type: Book
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  • Published: 2021-02-25
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  • Publisher: CRC Press

The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals effectively treat children with the most appropriate medicine with minimal side effects.

Biosimulation in Drug Development
  • Language: en
  • Pages: 540

Biosimulation in Drug Development

This first comprehensive survey to cover all pharmaceutically relevant topics provides a comprehensive introduction to this novel and revolutionary tool, presenting both concepts and application examples of biosimulated cells, organs and organisms. Following an introduction to the role of biosimulation in drug development, the authors go on to discuss the simulation of cells and tissues, as well as simulating drug action and effect. A further section is devoted to simulating networks and populations, and the whole is rounded off by a look at the potential for biosimulation in industrial drug development and for regulatory decisions. Part of the authors are members of the BioSim Network of Excellence that encompasses more than 40 academic institutions, pharmaceutical companies and regulatory authorities dealing with drug development; other contributors come from industry, resulting in a cross-disciplinary expert reference.