Proof of efficacy

According to a formulation of Heinrich (1976, p. 27), psychotic syndromes which are characterized by a lively emotional mobility, wealth of symptoms, active 

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A minor precedent for premarket testing of chemicals in the 1938 law had been established, on a voluntary basis, shortly after the 1906 law had gone into effect, with respect to coal-tar dyes used to color foods (98). The new drugs clause of 1938, in its turn, became a more significant precedent for later laws requiring the establishment of safety before the release of pesticide chemicals (1954), food additives (1958), color additives (1960), and medical devices (1976) (99, 100). In 1962, by the Kefauver-Harris Amendments, the Congress added the requirement that proof of efficacy be demonstrated before a new drug could be released. 

Additional ADRs linked to diet pills include psychosis myocardial ischemia drug interactions, such as the interaction of fenfluramine with imipramine, fenfluramine with amitriptyline or desipramine, or the toxic reaction between fluoxetine and phentermine and the release of serotonin while inhibiting its reuptake, contributing to hyperserotonin reactions. When the next craze takes hold of patients and their physicians, hopefully physicians and pharmacists will take a more vocal position and recommend restraint, xmtil some proof of efficacy and lack of toxicity is shown for new faddish off-label combinations. 

Proof of efficacy - ho to determine if a potential product ill have medical benefit ... 

Kanowski S, Herrmann WM, Stephan K, Wierich W, Hdrr R. (1996). Proof of efficacy of the Ginkgo biloba special extract EGb 761 in outpatients suffering from mild to moderate primary degenerative dementia of the Alzheimer type or multi-infarct dementia. Pharmacopsychiatry. 29(2) 47-56. 

In 1962, amendments to the Federal Food, Dmg, and Cosmetic Act added a proof-of-efficacy requirement to new drug approvals before that time, the FDA approved drugs for safety only. As a result of the amendments, brand-name companies are required to prove that new drugs are safe and effective prior to FDA approvd. To prove safety and efficacy, brand-name companies are required to conduct tests on humans ( clinical trials ) and to submit those results to the FDA with their new drug application (NDA). 

Proof of efficacy is lacking for the use of antacids for this condition but they are cheap, simple to take and, in ordinary doses, non-toxic. 

Individual management interventions also exist which must be attempted and adapted, even in severe forms of dementia. The absence of scientific evidence or proof of efficacy of these methods should not prevent their application. It is essential to promote interventional studies in this field. 

Another approach to tissue oxygenation, which consists of administering an aqueous suspension of O2 nanobubbles osmotically stabilized by a volatile PFC (e.g., F-pentane) and a fluorinated surfactant, appears promising. Experimental proof of efficacy for this system includes survival of erythrocyte-depleted rats and pigs, and of pigs with potentially lethal hemorrhagic shock and with severe right-to-left shunt [33],... 

A retrospective specification when the results from all or some of the studies are known should be avoided... There are, however situations where the need for a meta-analysis becomes apparent after the results from some or sometimes all studies are known. This is the case when there is a need to put seemingly conflicting results into perspective, or in the exceptional situation where a meta-analysis seems to be the only way to provide reliable proof of efficacy ... 

Methodological questions regarding the proof of efficacy of psvchopharma-ceuticals will be discussed in more detail in Chapter 5. 

Proof-of-efficacy trials these studies should provide, within a limited time frame and with a low-cost program, sufficient information for a go/no-go decision concerning efficacy and safety aspects of a new compound. The traditional approaches are Phase lib trials based on placebo-controlled dose-finding designs. These studies need relatively high power, which means the inclusion of several dozen to several hundred patients. 

Food, Drug, and Cosmetic Act of 1938 Required that new drugs be safe as well as pure (but did not require proof of efficacy). Enforcement by FDA. 

The conventional proof of efficacy is still the key to product registration and market entry, but in the new, information-intensive environment it brings no competitive advantage. Those responsible for the purchase of pharmaceuticals have begun to demand proof of value, which is to be found in information on the medical and economic outcomes of treatment, and the best means to those ends. Proof of efficacy can usually suffice as proof of value if it applies to the first curative medicine for a hitherto untreatable disease, but hardly so when the choice is among multiple, like-indicated, differently priced agents. 

Kefauver-Harris Amendments Required proof of efficacy as well as safety for new drugs and for... 

In parallel with animal experiments, Vane and colleagues (89) showed that intravenous teprodde reduced the pressor activity of angiotensin I in humans. Nor was there any significant augmentation or reduction of angiotensin II s hypertensive response. A biochemical proof of efficacy had been achieved, and clinical antihypertensive studies were begun. 

Proof of efficacy of a certain (surgical or medicinal) therapeutic measure - and this also applies in hepatology - is very difficult, as it mainly depends on two factors ... 

The 1962 amendments also require proof of efficacy before a new drug is approved for marketing. This proof is obtained by conducting clinical trials and is submitted to the FDA as part of the NDA for marketing approval.f ... 

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