Medications in development

Hovinga CA. Novel anticonvulsant medications in development. Expert Opin Investig Drugs 2002 ff f 387-406. 

In pharmaceutical and medical device development, clinical trials are classified into four main phases designated with Roman numerals 1,11, III and lY The various phases of development trials differ in purpose, length and number of subjects involved. Phase I trials are conducted to determine safe dose levels of a medication, treatment or product (National Institutes of Health, 2002). The main purpose is often to determine an acceptable single dosage - how much can be given without causing serious side-effects. Phase I trials will also involve studies of metabolism and bioavailabity (Pocock, 1983). The sample size of a Phase 1 clinical trial is usually small, ranging from 10-80 subjects (National Institutes of Health, 2002 Pocock, 1983). 

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... 

NSAIDs are one of the most widely used classes of medications in the United States, particularly in the elderly.4 More than 20,000 deaths occur in the United States per year as a direct result of adverse events related to NSAID use. Chronic NSAID ingestion leads to symptoms of nausea and dyspepsia in nearly half of patients. Peptic ulceration occurs in up to 30% of patients who use NSAIDs chronically, with gastrointestinal bleeding or perforation occurring in 1.5% of patients who develop an ulcer. NSAID-related peptic ulcers usually occur in the stomach duodenal ulcers are much less common. 

Because ketones are passed out of the body in the urine, a doctor can detect the onset of diabetic acidosis by doing a urine test. If ketones are present in the urine, it is a signal to the doctor that the patients diabetes is out of control. Without treatment, the patient could get very sick. On rare occasions, even Type I or Type II diabetics who take their medication can develop acidosis, usually as a result of some other serious health issue such as an infection or a heart attack. 

The collaboration between mental health services and members of families of people with mental illness and their other carers is of essential importance in developing a useful and successful mental health service. Collaboration with carers is not in existence in many of the Third World countries, and in places where it exists it is at present often restricted to a one-way communication of instruction of what the carers should do to assist in the realization of the treatment plan established by the medical practitioners. Advice from carers and information about the effects of treatment can both be of great value in the treatment of individual patients and in deciding the best use of medications and other treatments in health services in general. 

Kehoe was a smooth and practiced expert witness at government and judicial hearings. He opened his testimony by boasting that he knew more about lead than anyone else in the world. He boasted that he had served as the Ethyl Corporation s medical director because I was the only person who was familiar with the toxicology of tetraethyl lead and with the occupational hazards associated with its manufacture and distribution.. . . In developing the information on this subject (lead), I have had a greater responsibility than any other person in this country. Kehoe proudly... 

Asthma is the most serious of the atopic diseases and has become epidemic, affecting more than 155 million individuals in the developed world. It is the most common chronic childhood disease in developed nations [1], and carries a very substantial direct and indirect economic cost worldwide [2]. A number of pharmacological treatments have been developed for asthma. These treatments have a modest efficacy overall, due in part to widely variable individual responses to asthma drugs. Because of such variability, it is clear that some of the substantial resources expended on asthma medication, estimated to exceed U.S. 3 billion per annum in the U.S. alone [3], would be better spent targeting those patients who... 

There is less risk of developing motor complications from monotherapy with dopamine agonists than from L-dopa. Because younger patients are more likely to develop motor fluctuations, dopamine agonists are preferred in this population. Older patients are more likely to experience psychosis from dopamine agonists therefore, carbidopa/L-dopa may be the best initial medication in elderly patients, particularly if cognitive problems or dementia is present. 

Up to now odoriferous changes due to disease have been investigated in humans almost entirely from the medical perspective without any evolutionary perspective. This could be due to the fact that most researchers live in developed countries where numerous life threatening infections have been almost eradicated and thus can be supposed to be something unusual. However, this is definitely not true in the rest of the world and similarly over human history. Infections and parasites were the main... 

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