Lectures Given By The Invited Speakers At The Fifth European Congress Of Biopharmaceutics And Pharmacokinetics Brussels Belgium April 20 22 1993

In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.

Specifically geared to personnel in the pharmaceutical and biotechnology industries, this book describes the basics and challenges of oral bioavailability – one of the most significant hurdles in drug discovery and development. • Describes approaches to assess pharmacokinetics and how drug efflux and uptake transporters impact oral bioavailability • Helps readers reduce the failure rate of drug candidates when transitioning from the bench to the clinic during development • Explains how preclinical animal models – used in preclinical testing – and in vitro tools translate to humans, which is an underappreciated and complicated area of drug development • Includes chapters about pharmacokinetic modelling, the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the Extended Clearance Classification System (ECCS) • Has tutorials for applying strategies to medicinal chemistry practices of drug discovery/development

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.

This book contains suggestions for and reflections on the teaching, learning and assessing of mathematical modelling and applications in a rapidly changing world, including teaching and learning environments. It addresses all levels of education from universities and technical colleges to secondary and primary schools. Sponsored by the International Community of Teachers of Mathematical Modelling and Applications (ICTMA), it reflects recent ideas and methods contributed by specialists from 30 countries in Africa, the Americas, Asia, Australia and Europe. Inspired by contributions to the Fourteenth Conference on the Teaching of Mathematical Modelling and Applications (ICTMA14) in Hamburg, 2009, the book describes the latest trends in the teaching and learning of mathematical modelling at school and university including teacher education. The broad and versatile range of topics will stress the international state-of-the-art on the following issues: Theoretical reflections on the teaching and learning of modelling Modelling competencies Cognitive perspectives on modelling Modelling examples for all educational levels Practice of modelling in school and at university level Practices in Engineering and Applications

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Nanoengineering: Global Approaches to Health and Safety Issues provides a global vision on the impact of engineered nanomaterials both for the consumer/general public and in occupational settings. The book also presents a hint on what can be expected for the future from nanomaterials and their effects on our lives, both at home and at work. In addition, users will find valuable information on nanomaterials' irreplaceable value and their risks for health, safety, and environmental issues. Case studies illustrate key points and provide information on important processes. Provides a global vision on the different aspects related to nanosafety and a synthesis of the information available Gives all the information required for precision decision-making in a single book, offering both general public and occupational aspects Contains separate chapters on each subject written by world-renowned contributors Presents a complete vision of the problem, with perspectives on global approaches Includes case studies that illustrate important processes

Encyclopedia of Pharmacy Practice and Clinical Pharmacy, Three Volume Set covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos

A concise compilation of the known interactions of the most commonly prescribed drugs, as well as their interaction with nonprescription compounds. The agents covered include CNS drugs, cardiovascular drugs, antibiotics, and NSAIDs. For each class of drugs the authors review the pharmacology, pharmacodynamics, pharmacokinetics, chemistry, metabolism, epidemiological occurrences, adverse reactions, and significant interactions. Environmental and social pharmacological issues are also addressed in chapters on food and alcohol drug interactions, nicotine and tobacco, and anabolic doping agents. Comprehensive and easy-to-use, Handbook of Drug Interactions: A Clinical and Forensic Guide provides physicians with all the information needed to avoid prescribing drugs with undesirable interactions, and toxicologists with all the data necessary to interpret possible interactions between drugs found simultaneously in patient samples.