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Biomedical subjects

E S Snell

Publications and source records attributed to E S Snell.

12 recordsLinked to original sources
PubMed1986

Regulatory decisions and the pharmaceutical industry.

National regulations on medicines are generally accepted as an important mechanism for ensuring that only medicines of adequate quality, safety and efficacy are available in the community. However, there are potential adverse effects of such regulations which should be kept within limits as far as possible. The recent history of non-steroidal anti-inflammatory drugs (NSAIDs) with withdrawal of 9 drugs in 6 years suggests that something is wrong with the current system and that improvements are needed. Attention is drawn to 3 key areas. Firstly, that a number of general conditions are important in the relationship between regulators and pharmaceutical companies. Secondly, the long life cycle of a medicine contains 2 phases for regulatory decisions--pre-marketing and post-marketing--but there is a discrepancy in the data, criteria and standards used in each. A new medicine is licensed on the basis of a large amount of accurate, scientific laboratory and clinical data, but, of necessity, before experience is available from general field use. Hence, research continues after marketing in respect of efficacy and safety in the new situation of ordinary field use. Usually this enables refinements to be made in methods of use and sometimes very useful new formulations or dramatic new uses of the drug are discovered. Testing for efficacy is accurate and becoming further refined by measuring the quality and duration of life provided by medicines. Suspicions of rare serious reactions are easily raised by a few anecdotal reports but are much more difficult to test, as accurate data are not available.(ABSTRACT TRUNCATED AT 250 WORDS)

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1976

The pharmacological properties of corticosteroids in relation to clinical efficacy.

The pharmacological properties of cortisol (and cortisol-like drugs) are divided into several distinct activities according to the type and cellular site of action of the hormone. To each of these discrete properties is allotted the separate clinical beneficial responses and the adverse effects that probably arise from them. For any one patient only one, or two, of these pharmacological properties are desirable and the remainder are undesirable. Therapy aims to separate the wanted from unwanted effects and this can be attempted in three ways: firstly, by adjustment of dose, frequency and duration of corticosteroid administration; secondly by delivery of the drug directly only to the site of disease--if this is possible; and thirdly, by using analogues which have been synthesized with 'tailor-made' selective actions. Synthetic analogues have not yet offered much selectivity of action of value for systemic use, but for local use (as on the skin and in the respiratory tract) such analogues have provided a considerable therapeutic advance. It is suggested that the several distinctive pharmacological properties of cortisol (as well as the existence of other steroids closely related chemically but with widely different biological activities, such as progestagens and anaesthetics) offer hope for the synthesis of cortisol-like compounds with much greater selectivity in systemic action.

Adrenal Cortex Hormones↗