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Clinical trials approval

GBL All products containing GBL 01/22/1999 05/11/1999 08/25/1999 GBL is converted to GHB in vivo. At that time GHB was banned outside of clinical trials approved by the FDA. GHB has been implicated as a potential date rape drug... [Pg.16]

Thus, we now have several well-validated, efficacious forms of treatment for this common debilitating disease. In Europe, strontium ranelate has been used for several years with favorable results in large clinical trials approval for use in the USA is expected. [Pg.962]

The State Institute for Drug Control is responsible for supervision in the pharmaceutical sector, medical device approval, the registration process, clinical trial approval, withdrawcil of drugs cmd medical devices, control of advertising and inspection of GMP, GLP and GCP. [Pg.629]

In the Central and Eastern Region (CEE) of Europe, the clinical trials approval system continues to evolve rapidly. In general, the regulations are converging towards the EU model of submission and approval, but local practices make... [Pg.648]

Very few places charge a significant administration fee for a clinical trial approval (although... [Pg.693]

Few developed States currently charge a significant administration fee for a clinical trials approval (Massachusetts is one example). In less developed countries it may prove necessary to pay true fees together with consultation fees to government advisors. Sponsors will, however, need to take into account the costs associated with the effort of their internal regulatory staff in preparing CTX submissions (or their equivalent). [Pg.505]

Human growth hormone, used as a human pharmaceutical, is approved for only one indication in the United States, treatment of growth failure owing to hGH deficiency, a condition known as pituitary dwarfism. However, clinical trials are under way to test its efficacy in Turner s syndrome, bums, wound healing, cachexia, osteoporosis, constitutional growth delay, aging, malnutrition, and obesity. [Pg.196]

Certain neutral technetium complexes can be used to image cerebral perfusion (Fig. 4). Those in Figure 4a and 4b have been approved for clinical use. Two other complexes (Fig. 4c and 4d) were tested in early clinical trials, but were not developed further. An effective cerebral perfusion agent must first cross the blood brain barrier and then be retained for the period necessary for image acquisition. Tc-bicisate is retained owing to a stereospecific hydrolysis in brain tissue of one of the ester groups to form the anionic complex TcO(ECD) , which does not cross the barrier. This mechanism of retention is termed metaboHc trapping. [Pg.478]

Adjuvants are substances which can modify the immune response of an antigen (139,140). With better understanding of the functions of different arms of the immune system, it is possible to explore the effects of an adjuvant, such that the protective efficacy of a vaccine can be improved. At present, aluminum salt is the only adjuvant approved for use in human vaccines. New adjuvants such as QS-21, 3D-MPL, MF-59, and other liposome preparations are being evaluated. Several of these adjuvants have been in clinical trial, but none have been approved for human use. IL-12 has been proposed as an adjuvant which can specifically promote T-helper 1 ceU response, and can be a very promising adjuvant for future vaccine development. [Pg.361]

Clinical trials in Bra2H in 1977 of the oral adininistration of ribavirin prompted the Bra2iUan government to approve its use for treating infectious hepatitis A (126). Because ribavirin is water-soluble, it can be dispersed readily in a fine-particle aerosol. Clinical trials (127) indicate that such aerosols... [Pg.312]

Approaches to cytotoxic chemotherapy iaclude special emphasis on dmg targeting and toxicity alleviation. The directions ia which new dmg discovery strategies are moving and the criteria used for advanciag compounds iato clinical trials (2) are discussed hereia, as are all of the dmgs approved by the United States Food and Dmg Administration (FDA) for the treatment of cancer as of this writing and those compounds ia clinical trials. [Pg.433]

All preparations of enzymes intended for parenteral use are tested for safety in lower animals under the conditions anticipated in clinical trials ie, their use must be nonpyrogenic in the USP rabbit assay (255), and must be sterile. Such toxicologic studies are usually a prerequisite for approval by the FDA for the sale of such pharmaceuticals. [Pg.314]

Presently, only adenosine itself is approved for clinical use. It is used widely in the treatment of supraventricular tachycardia and in cardiac stress imaging to assess coronary artery disease [5]. Other agonists and antagonists and an allosteric modulator of the Ai receptor are in clinical trials for a variety of indications. [Pg.27]

In the aitways, inhibition of PDE4 is much more antiinflammatory than bronchodilatory. Although effective in animal experiments, the neuronal and gastric side effects of PDE4-inhibitors have so far impeded their use in humans. Two new orally active PDE4-inhibitors (roflumilast, cilomilast) have shown some effectiveness in advanced clinical trials, but have not yet been approved. [Pg.287]

The first clinical trials were performed in the 1970 s using a sodium salt derivative with an open E-ting (Fig. 1). However, the clinical efficacy was limited and severe bladder toxicity led to the termination of the clinical trials. The poor efficacy of the camptothecin sodium salt in those clinical trials was probably due to the fact that the open E-ring form of camptothecin (carboxylate derivative) is inactive as a Topi inhibitor. Following the identification of Topi as a target of camptothecin, water-soluble derivatives were produced by the pharmaceutical industry. Two of these water-soluble derivatives have been approved by the FDA for cancer treatment in the early 2000s topotecan and irinotecan. [Pg.315]


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See also in sourсe #XX -- [ Pg.108 ]




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Clinical trials drug approval process

Postmarketing approval, clinical trials

Postmarketing approval, clinical trials phase

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