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[Deontological problems in pharmacology].

Scientific and technological progress in the XX century had a great impact on the development of pharmacology. Deontological problems are quite urgent in modern pharmacology. The philosophical, moral and ethical, social and economic concepts play a significant role in it. THe drugs in the developed countries are manufactured on a fairly large scale, medical service makes up an important part of the state expenses. The quality of the medical service affects the productive forces of the country. The modern highly active drugs have to be properly and skillfully employed. The drugs should be examined first in experiments on animals on then in clinics in accordance with the scientific and deontological principles.

Animals↗
PubMed1994

Bungyo in Japan.

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Drug Prescriptions↗
PubMed1994

Human volunteer studies with non-pharmaceutical chemicals: metabolism and pharmacokinetic studies.

1. Human volunteer studies are an essential part of drug development but their use in the area of non-pharmaceutical chemicals has so far been very limited. Such studies can have considerable value in the assessment and improvement of the safe use of chemicals. 2. Once metabolic pathways and target metabolites have been identified in volunteers this information can be used in studies in the workplace or in the general population. Studies should be performed selectively only if there is both a toxic hazard and a significant exposure potential. In addition, they should only be carried out if the required information cannot be obtained in any other way. 3. Volunteer studies with non-pharmaceuticals have become increasingly acceptable in the light of established international guidelines, no-fault compensation, improvements in study design and technical developments which allow the use of very low dose levels. The final decision on whether to carry out a study must always rest with an independent ethical committee. 4. The practical aspects of the study should be specified in a detailed protocol conforming with the principles of good clinical practice. The safety of volunteers must be of paramount concern throughout. Depending on the nature of the chemical and the study, it may be advisable to carry out studies in a clinical facility where equipment is available for the treatment of any emergencies that might occur. 5. Numerous investigators have now shown that human volunteer studies are ethically acceptable, practicable and yield important information. The risk to volunteers is minimal and this approach can lead to an improved foundation for occupational hygiene standards, more accurate risk assessment and thus better protection of the workforce and the general population.

Animals↗