The changing scene of the regulation of medicines in the UK. Paper from The Use of Medicines: Regulation & Clinical Pharmacology in the 21st Century Symposium - December 2003. (25/152)

The Medicines and Healthcare products Regulatory Agency was established in April 2003 by the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). This paper describes the scientific and organizational basis for the merger and describes the various challenges facing this new Agency.  (+info)

The use of pharmacokinetic and pharmacodynamic data in the assessment of drug safety in early drug development. (26/152)

The pharmaceutical industry continues to look for ways to reduce drug candidate attrition throughout the drug discovery and development process. A significant cause of attrition is due to safety issues arising either as a result of animal toxicity testing or in the clinical programme itself. A factor in the assessment of safety during early drug development is the pharmacokinetic profile of the compound. This allows safety data to be considered in the light of systemic drug exposure and therefore permits a quantitative assessment. This is particularly applicable when assessing the risk of a new chemical entity (NCE) in relation to safety parameters such as QT interval prolongation, where free plasma concentrations have been shown to be predictive of this property in relation to potency in preclinical testing. Prior to actual human exposure it is therefore important to be able to predict reliably the pharmacokinetic behaviour of an NCE in order to place such safety findings into a quantitative risk context. The emerging science of pharmacogenetics is likely to further our ability to assess the risk of NCEs to populations and individuals due to genetic variance. The drug metabolizing enzyme CYP2D6 has been recognized as providing the potential to result in widely differing systemic drug exposure in the patient population due to polymorphic expression. Further knowledge is likely to add to our understanding of population differences in exposure and response and aid in the identification of risk factors. One potential strategy for improving the effectiveness of the drug discovery process is to obtain clinical pharmacokinetic data more rapidly in order to assess more accurately the potential for both efficacy and safety of an NCE. Whilst procedures and technologies are available that allow this on the microdose scale, it is important that we recognize potential limitations of these approaches in order that they can be applied beneficially.  (+info)

Ethical issues in funding orphan drug research and development. (27/152)

This essay outlines the moral dilemma of funding orphan drug research and development. To date, ethical aspects of priority setting for research funding have not been an issue of discussion in the bioethics debate. Conflicting moral obligations of beneficence and distributive justice appear to demand very different levels of funding for orphan drug research. The two types of orphan disease, rare diseases and tropical diseases, however, present very different ethical challenges to questions about allocation of research funds. The dilemma is analysed considering utilitarian and rights based theories of justice and moral obligations of non-abandonment and a professional obligation to advance medical science. The limitations of standard economic evaluation tools and other priority setting tools used to inform health policy decision makers on research funding decisions are outlined.  (+info)

From physical pharmacy to clinical pharmacology. (28/152)

Research works on molecular interactions in solutions were carried out at School of Pharmacy, the University of Wisconsin under the direction of Prof. T. Higuchi and at Faculty of Pharmaceutical Sciences, Kyoto University under the direction of Prof. H. Sezaki. Studies on permeation of drugs through polymer membranes were carried out at Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada and at Pharmaceutical Chemistry Research Laboratories at Food and Drug Directorate, Department of Health and Welfare, Canada. Studies on modification of delivery patterns by means of pharmaceutical approaches were carried out at Faculty of Pharmaceutical Sciences, Hokkaido University. Topics related to modification of drug delivery patterns include employment of amorphous forms such as ground mixture with micro-crystalline cellulose and coprecipitate with polyvinylpyrrolidone, use of biodegradable polymers such as polylactic acid and polycarbonates, gel-forming materials such as konjac, agar and hydroxypropylcellulose, and physicochemical systems such as complexation. Works related to drug delivery and disposition of drugs in humans were carried out at Department of Pharmacy, Kumamoto University Hospital. Topics related to drug delivery in humans include injections containing anticancer drugs for intra-arterial administration, lidocaine gels for dermal anesthesia, glucagon solution for nasal administration. Topics related to disposition of drugs in humans include clinical pharmacokinetic studies in infants and elderly and medical uses of adsorbents.  (+info)

Passing the Diploma in Immediate Medical Care of the Royal College of Surgeons of Edinburgh. (29/152)

The Diploma in Immediate Care of the Royal College of Surgeons of Edinburgh is increasingly recognised as a gold standard for immediate care practitioners, including doctors with a significant involvement in prehospital care, paramedics who wish to enhance their knowledge base or obtain the Diploma as an entry requirement for a post registration degree, and for nurses who have a recognised and developing role in the evolving emergency medical services. This paper provides information about the Diploma examination including eligibility, the syllabus and the components of the examination, and comments on the reason for failure and provides suggestions for training and education to enhance the candidate's opportunity of passing the examination.  (+info)

Application of a static fluorescence-based cytometer (the CellScan) in basic cytometric studies, clinical pharmacology, oncology and clinical immunology. (30/152)

The CellScan apparatus is a laser scanning cytometer enabling repetitive fluorescence intensity (FI) and polarization (FP) measurements in living cells, as a means of monitoring lymphocyte activation. The CellScan may serve as a tool for diagnosis of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) as well as other autoimmune diseases by monitoring FP changes in peripheral blood lymphocytes (PBLs) following exposure to autoantigenic stimuli. Changes in FI and FP in atherosclerotic patients' PBLs following exposure to various stimuli have established the role of the immune system in atherosclerotic disease. The CellScan has been evaluated as a diagnostic tool for drug-allergy, based on FP reduction in PBLs following incubation with allergenic drugs. FI and FP changes in cancer cells have been found to be well correlated with the cytotoxic effect of anti-neoplastic drugs. In conclusion, the CellScan has a variety of applications in cell biology, immunology, cancer research and clinical pharmacology.  (+info)

It's time. (31/152)

Statistical inference involves taking the results of models and knowledge about probability to make decisions about the relationship in question. This commentary explains the usefulness of statistical inference to the drug development process, as well as some common pitfalls. It also examines reasons why statistical inference does not seem to be fully integrated into pharmacometric modeling. An example is shown that demonstrates the inferential advantages of mechanistic models. Both statisticians and pharmacometricians ought to take note of these advantages and integrate their efforts in order to maximize the decision-making potential of clinical research.  (+info)

A brief history of the British Pharmacological Society. (32/152)

The article traces the history of the BPS since its inception in 1931 until the present day. Details are given about the size and nature of the membership and how the governance of the Society has changed during the last 75 years. The emergence of the Clinical Section from within the main Society and the growth of the Society's publications are described.  (+info)