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Biomedical subjects

Alasdair Breckenridge

Publications and source records attributed to Alasdair Breckenridge.

10 recordsLinked to original sources
PubMed2005

Monitoring the safety of licensed medicines.

The withdrawal of the selective cyclooxygenase 2 inhibitor rofecoxib owing to cardiovascular side effects ignited debate about the need for major changes to current mechanisms for post-marketing surveillance (PMS) of drug safety. Here, we discuss the current mechanisms, whether they are being used appropriately, and consider the need for changes to regulatory systems.

Databases, Factual↗
PubMed2004

Pharmacogenetics: ethical problems and solutions.

Regulators, drug companies, academic scientists, bioethicists, clinicians and, increasingly, the general public are starting to realize that pharmacogenetics (PGx) will probably have a huge impact on the way in which we treat both common and rare diseases. But how much thought has gone into the ethical issues that the incorportation of phamacogenetic testing into drug discovery, prescription and use will entail? It seems that "quite a bit" is the answer, as the diverse viewpoints of representatives of all of these groups presented here illustrate. However, these views also highlight that now is the time to start formulating and implementing solutions to these potential problems.

Ethics, Medical↗
PubMed2004

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.

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.

Drug Approval↗
PubMed2004

Therapy of falciparum malaria in sub-saharan Africa: from molecule to policy.

The burden of falciparum malaria remains as great as ever, and, as has probably always been the case, it is carried mainly by tropical Africa. Of the various means available for the control of malaria, the use of effective drugs remains the most important and is likely to remain so for a considerable time to come. Unfortunately, the extensive development of resistance by the parasite threatens the utility of most of the affordable classes of drug: the development of novel antimalarials has never been more urgently needed. Any attempt to understand the vast complexities of falciparum malaria in Africa requires an ability to think "from molecule to policy." In consequence, the review ambitiously tries to examine the current pharmacopeia, the process by which new drugs are developed and the ways in which drugs are actually used, in both the formal and informal health sectors. The informal sector is particularly important in Africa, where around half of all antimalarial treatments are bought from informal outlets and taken at home without supervision by health care professionals: the potential impact of adherence on clinical outcome is discussed. Given that the full costs are carried by the patient in a large proportion of cases, the importance of drug affordability is explored. The review also discusses the splicing of new drugs into national policy. The various parameters that feed into deliberations on changes in drug policy are discussed.

Adolescent↗
PubMed2003

For the good of the patient: risks and benefits of medicines.

The basis of regulation of medicines is an assessment of risk and benefit. As the process of drug development has evolved with the advances in scientific knowledge, new and more precise methods of measuring drug efficacy have been created. Pharmacovigilance must also change with as much emphasis being placed on demonstrating the safety of a medicine as on preventing harm. Communication of these issues to interested parties remains problematical with room for considerable improvement.

Communication↗
PubMedDate not supplied

William Withering's legacy--for the good of the patient.

The lessons that the physician William Withering learned from his studies of digitalis are still relevant today. This paper highlights four of these lessons and updates them using the tools of clinical pharmacology and pharmacoepidemiology. First, Withering learned that failure to prepare digitalis from the foxglove in a standard manner resulted in a product with unpredictable clinical effects. Preparation of medicines from plants since then has not followed similar good practice and medicines have often not been granted marketing authorisation because of variability in their quality. Second, differences in the response to digitalis were noted by Withering, but he had little idea of their basis. Clinical pharmacology has shown that for drugs such as digitalis differences are caused by variability both in receptor sensitivity and in drug disposition. Third, the dose-response characteristics of digitalis were well known to Withering. Modern techniques of measuring response, such as the use of biomarkers, have made such studies easier, although clinical observations remain the gold standard. Fourth, Withering documented many of the adverse effects of digitalis. The use of various modern databases has facilitated the analysis of clinical toxicology and thus of risk-benefit profiles.

Biological Availability↗