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Wednesday, July 28, 2010

Understanding Drug Release and Absorption Mechanisms: A Physical and Mathematical Approach

Demand for better reliability from drug delivery systems has caused designers and researchers to move away from trial-and-error approaches and toward model-based methods of product development. Developing such models requires cross-disciplinary physical, mathematical, and physiological knowledge. Combining these areas under a single cover, Understanding Drug Release and Absorption Mechanisms builds a firm understanding ofall elements needed to conceive, build, and implement successful models of drug release.
Written by experts with broad industrial and academic experience, this book discusses the underlying physical principles, shows how to build mathematical models based on these principles, and finally compares the resulting models with experimental results. The authors begin by introducing the basics of modeling, physiological details of gastrointestinal and dermal absorption pathways, rheology, mass transport and thermodynamics, dissolution and partitioning, as well as size effects on the dissolution of crystallites. From this baseline, the authors explore applications in drug release from various delivery systems, specifically matrix systems, microemulsions, and permeability through membranes.
Working systematically from theory to working models, Understanding Drug Release and Absorption Mechanisms: A Physical and Mathematical Approach demonstrates the steps involved in designing, building, and implementing realistic and reliable models of drug release without unrealistically simplifying the theoretical parameters.

Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition

This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. Using current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently. Chapters include: Overview of Clinical Research, FDA Regulations and Good Clinical Practice Guidelines, The Study: Planning Stages and Commencement, Interactions with the Sponsor, Interactions Within the Institution; The Role of the Study Subjects, Data Management: Adverse Events, Investigational Agent Management, and Inspection of Clinical Research Sites.

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Statistical Thinking for Non Statisticians in Drug Regulation

Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statistician working within a very strict regulatory environment. Statistical Thinking for Clinical Trials in Drug Regulation presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context. As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation.
Statistical Thinking for Clinical Trials in Drug Regulation:
  • Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language
  • Improves the ability to read and understand statistical methodology in papers and reports and to critically appraise that methodology
  • Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)

Effective drug regulation: A multicountry study

Drugs play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. But they need to be safe, efficacious, of good quality, and used rationally. This means that their production, import/export, storage, supply and distribution should be subject to government control through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It gives an overview of the development of drug regulation in these countries as well as the resources available and the strategies applied in drug regulation implementation at the time the studies were conducted. An analysis of the strengths and weaknesses in drug regulation in these countries is also provided.



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