Clinical Pharmacology

Clinical pharmacology, the science of interactions between men and drugs, was forged as an established medical discipline in the late 1950s and early 1960s in the United States, the United Kingdom, and Scandinavia. By 1970, it had been recognized by World Health Organization (WHO) and in the same year the Clinical Pharmacology section of the British Pharmacological Society was formed. In 1974 the British Journal of Clinical Pharmacology was launched. Clinical pharmacology has developed unevenly within the European region and indeed throughout the world. It has developed rather at a faster pace in some countries (e.g., the United Kingdom, Scandinavia) but slower in others. The functions of clinical pharmacology were defined 30 years ago in a WHO report as research, teaching and service functions to enhance the "scientific study of drugs." Pharmacological service functions are referred to functions aiming to solve problems in drug therapy, not to traditional clinical work. In retrospect it is felt in Europe that most clinical pharmacology groups who lived up to the recommendation of this WHO report have evolved favorably, while many of those who did not, have disappeared [6].

There are different descriptions of clinical pharmacology. It is considered as both a research discipline (interdisciplinary) and a clinical specialty (specified training of MDs). Under ideal circumstances they work closely together, and there is a career ladder for both. At times, there has been tension between a conservative clinical specialist approach, at the cost of isolation, and a broader multidisciplinary-in-touch approach. However, to meet various challenges in Europe, old barriers divided along traditional subject lines, are being replaced in both academia and industry by interdisciplinary teams [6].

Four decades of clinical pharmacology research (1960-2000) have emphasized different aspects of the discipline (see Table 1) from controlled clinical trials and drug metabolism during the early 1960s to molecular pharmacogenetics and pharmacoeconomy during the late 1990s [6] (also see Section 2 of this chapter).

In Europe, clinical pharmacology continues to be driven by a thriving pharmaceutical industry, much of which is West-European based. Its

TABLE 1 Four Decades and Different Aspects of Clinical Pharmacology [8]

• 1960-1970 Controlled clinical trial, adverse drug effects, drug metabolism,

• 1970-1980 Drug interactions, pharmacogenetics, therapeutic drug monitoring, improved methods to assess drug response, improved drug evaluation

• 1980-1990 Pharmacoepidemiology, pharmacovigilance, individualization of

• 1990-2000 Molecular pharmacogenetics, pharmacokinetic-pharmacodynamic modeling, population-based dose evaluation, pharmacokinetic optimization of drug effects, evidence-based pharmacotherapy, pharmacoeconomy.

development has been underpinned by the recognition that newly available drugs must be assessed in unbiased controlled clinical trials designed, conducted, and analyzed to the highest possible standards. Meanwhile, understanding of potential mechanisms of drug actions has improved, increasing the number of target sites for new drug development. Improved measurement techniques of both drugs and their metabolites, and the body's response to them, have increased the understanding of pharmacokinetics and pharmacodynamics [7].

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