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The terms ‘Good Clinical Practice’ and ‘Good Clinical Research Practice’ have entered the everyday vocabulary of the clinical researcher and imply a mystique around the subject that really does not exist. The purpose of good clinical practice is several-fold. It is to ensure, first, that persons who agree to participate in any clinical research protocol are protected from unnecessary risk as the study is conducted in accordance with a set of well-thought-out procedures; second, that the data collected from the study are of sufficiently high quality to fulfil the original purpose; third, that there is a means of auditing; finally, that the resources that have been expended on the study, human and financial, have been used to their best effect.

A T H O U G H the main of this article is purpose to describe the preclinical and clinical data on the systemic toxicity and efficacy of levobupivacaine in relation to its pharmacokinetics,* it is useful wherever possible to place levobupivacaine into the context of other local anesthetic agents used in contemporary regional anesthesia, particularly as related to chirality. The main currently used agents are lidocaine (lignocaine), prilocaine, mepivacaine, ropivacaine, and bupivacaine; etidocaine also qualifies for inclusion but is less studied and less used than the others. All are derived via various familial trees from the nearly century-old prototypic synthetic agent, procaine. Accordingly, all these agents have chemically in common a tipophilic aromatic "head," a linking "bridge" (an amide group in the contemporary agents rather than the ester group of the prototype procaine), and a hydrophilic "tail" by way of a conjugate acid of an alkyl-substituted amino group, They have pharmacologically in common their clinically indicated action of inhibiting the propagation of action potentials in excitable neuronal tissues as well as a number of side effects. The cumulative medicinal chemistry of these conventional local anesthetic agents has regularly shown that increased potency and duration of neu

Orexins have a role in sleep regulation, and orexin receptor antagonists are under development for the treatment of insomnia. We conducted a randomised, double-blind, placebo-controlled, four-period crossover study to investigate the effect of single doses of the dual orexin receptor antagonist SB-649868 (10 or 30 mg) and a positive control zolpidem (10 mg), an allosteric modulator of GABA(A) receptors. Objective and subjective sleep parameters and next-day performance were assessed in 51 healthy male volunteers in a traffic noise model of situational insomnia. Compared with placebo, SB-649868 10 and 30 mg increased total sleep time (TST) by 17 and 31 min (p

As a result of European legislation passed in 2001 (Directive 2001/20/EC), all clinical trials, whether sponsored by industry, a major national body or charity, or done by a single academic investigator, must get approval from the Medicines and Healthcare products Regulatory Agency (MHRA) as well as obtaining ethical approval. This requires all studies to be carried out to the standards of 'Good Clinical Practice' and places burdens on investigators in terms of reporting adverse events and archiving. A new directive has been published in draft form that will finally define what is meant by Good Clinical Practice in Europe.

The attainment of specialty status for pharmaceutical medicine with its own Certificate of Completion of Specialist Training (CCST), which is expected literally within the next few days, will be a major step in the evolution of the professional standing of those who have chosen to pursue a career in either the pharmaceutical industry or the regulatory authorities. Whilst at the moment this is for the UK, it is planned to take this forward to EU wide. In order to obtain a CCST it will be necessary for candidates to enrol on a programme of Higher Medical Training (HMT), which involves demonstrating a level of competence in seven modules of work that make up the curriculum. Obtaining the Diploma of Pharmaceutical Medicine is part of the process and it is assumed that most people will sit this about two years after joining the industry. At least three of the modules must be completed within the person’s place of work and it may be that, for some individuals, all of them can be completed this way. However, it is recognized that companies vary in size and structure and there is a wide diversity of jobs within pharmaceutical medicine. Thus, the Faculty of Pharmaceutical Medicine is arranging for a series of taught modules to be available so that people who cannot complete their training in the work place have an alternative route to obtaining all the necessary training for a CCST. These courses will be provided by a variety of organizations, such as the Medicines Control Agency, some pharmaceutical companies and some universities, and the Faculty will put in place a quality control process that ensures that the standards are maintained. The achievement of a CCST is a major step in anyone’s career development and it is important that those embarking on a career in pharmaceutical medicine have the same professional status as other medical disciplines. Getting this far is the result of a huge amount of work by a large number of people, but the two whom I would like to recognize for their skilful manipulations through the tortuous path that we trod are Professor David London and Professor Peter Stonier. It is to be hoped that future generations of patients and pharmaceutical physicians will acknowledge the service that they have done. INTERNATIONAL JOURNAL OF PHARMACEUTICAL MEDICINE 2002, 16:111 & 111