Michael D Young

Celltech Chiroscience PLC, Slough, UK Medicine is an art that has been practiced since time immemorial. The use of herbs and natural medicaments to relieve pain or to aid the sick in coping with their afflictions has been a part of all societies. In the Western world, medicine has developed at least since the time of the Greeks and Romans the Hippocratic oath reminds us of this nearly 2500 year history. However, the progress of medicine has been very different from that of many other arts...

Market Support Studies

In addition to the Rx-to-OTC switch, a second type of study is very prominent in the OTC area. This is the market support study. These are clinical studies intended to demonstrate particular advantages of one company's drug over another's, or of one particular formulation of the same drug over other competitors. Opportunities for demonstrating such advantages depend on locating genuine differences that can be successfully studied. While anything can be tried in a clinical study, only authentic...

Peptides

For a long time, interest in biotechnology centered on the production and properties of administered hormones ranging from tripeptides, e.g. cortico-trophin releasing factor (CRF) through nonapep-tides, such as vasopressin analogues to longer polypeptide chains, e.g. insulins and growth hormones. As the length of the molecule increases, the three-dimensional structure becomes an important determinant of in vivo activity and properties. However, there are also important freedoms that an increase...

Rectal

The use of suppositories is probably one of the clearest examples of cross-cultural differences in the approach to pharmaceuticals. A surgeon on a famous ocean liner has commented that 'Part of the problem of stocking one's pharmacy is that one needs three times as many drugs as when working on land tablets for the Brits, shots (injectables) for the Yanks, and suppositories for the French ' However, the route of administration is eminently logical, e.g. for the acute treatment of migraine,...

Prescriptiontootc Switch

One of the most dynamic areas in the pharmaceutical industry today is the prescription-to-OTC switch, commonly called the Rx-to-OTC switch. This is the process by which a drug that has previously been used only by prescription is converted to self-medication status. We have already considered the criteria for OTC use of medications and these criteria represent a sound guide to determining what drugs are suitable for switching. There are no hard and fast guidelines for determining which drugs...

Historical Clinical Trials

Any general work must include these classic bits of history. Perhaps unusually, clinical trials appear to be a European scientific invention. There is no evidence that either the ancient world or the mediaeval Arabs carried out prospective studies (although there are some anachronisms in recent fiction). It is generally accepted that the earliest clinical trial was held by James Lind. Thomas (1997) has pointed out that sailing men-of-war frequently went many months without docking, e.g. Nelson...

The Unique Characteristics Of The Otc Field From The Pharmaceutical Physicians Viewpoint

The role of the pharmaceutical physician in the OTC division of a major pharmaceutical company is substantially different from that played in the research or medical affairs departments dealing with prescription drugs. One might assume that OTC work is simpler and less involved than that related to prescription medications. In many ways, the opposite is true. The OTC pharmaceutical physician must be a generalist, requiring a broad expertise in medicine, toxicology, and regulatory affairs. The...

Training To Be A Pharmacoepidemiology

No parent has ever heard the statement 'Mummy (or Daddy), I want to be a pharmaceutical physician pharmacoepidemiologist when I grow up' Few physicians and very few pharmaceutical physicians choose this route. But what is along that route The 'high road', in the USA at least, is graduation from medical school, obtaining at least 1 year of intense clinical postgraduate training (often leading to internal medicine or other primary care boards, the equivalent of MRCP in the UK), and then to...

Genomics and New Target Identification

Drug companies have recently become involved in the use of genomics to identify new genes which might have some role in disease pathology. Molecular biologists can seek mutations or alterations in genetic signatures which are predictive of the targeted disease in a large population. If this mutation is always associated with the disease, they can then map this gene to the disease. This is known as 'linkage analysis'. When linkage analysis can predict that a disease-regulatory gene falls within...

Raymond J Townsend and Jane T Osterhaus 2J Gregory Boyer

1 Wasatch Health Outcomes, Park city, Utah, USA and 2Pharmacia Corporation, For most of the past 25 years, the development of most pharmaceutical products has followed a predictable path from discovery to preclinical and clinical development, approval and marketing. With the onset of increased competition, decision makers want to hold down healthcare costs while maintaining or increasing quality. This has dictated changes in the traditional drug development path. To maximize the...