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Legal Control of Drugs and Generic Drugs

Nursing, Law & Ethics, 1980
The regulation of the use and distribution of drugs in the United States is governed by a complex set of state and federal laws and regulations. These laws and regulations are designed to accomplish a variety of purposes. First, the federal government hopes to exclude from interstate commerce drugs that are not both “safe and effective.” This function ...
G J, Annas, L H, Glantz, B, Katz
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Generic Drugs

Drug Safety, 1996
For economic reasons, the use of generic substitution is increasingly being supported by health authorities. Potentially, this may be problematic for drugs with a narrow therapeutic window if quality control and/or bioequivalence is not optimal. Many developing countries do not have the resources or expertise to carry out appropriate quality control ...
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The Generic Inequivalence of Drugs

JAMA: The Journal of the American Medical Association, 1968
Generic equivalence of drugs is a semantically muddled concept. To be meaningful, the criteria for equivalence must be stated. In this simple study, two different formulations of tolbutamide, both generically equivalent in terms of chemical content and specifications of the United States Pharmacopoeia , were found to be clearly not equivalent as ...
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GENERIC DRUGS

Chemical & Engineering News Archive, 2002
Various incentives will progressively increase the part of generic drugs on the Belgian market place and will more and more confront the prescriber with the problem of substitution. The equivalence between generic and brand name products and the fear, justified or not, at efficacy or patient safety levels in case of substitution are discussed on the ...
  +6 more sources

Drug discovery for a new generation of covalent drugs

Expert Opinion on Drug Discovery, 2012
The design of target-specific covalent inhibitors is conceptually attractive because of increased biochemical efficiency through covalency and increased duration of action that outlasts the pharmacokinetics of the agent. Although many covalent inhibitors have been approved or are in advanced clinical trials to treat indications such as cancer and ...
Amit S, Kalgutkar, Deepak K, Dalvie
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DRUG‐INDUCED GENERALIZED PHOSPHOLIPIDOSIS

Acta Pathologica Japonica, 1972
Drug‐Induced generalized phosphollpldosis in human beings is described. Detailed study of phospholipid fatty liver, which was first reported by us in 1968, disclosed that phospholipid accumulation is not only found in the liver but is also distributed throughout the body.
T, Shikata   +3 more
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Reassurance about Generic Drugs

New England Journal of Medicine, 1987
The approval, marketing, and use of generic pharmaceutical agents in the United States have expanded greatly over the past two years.
G A, Faich   +4 more
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[Generic drugs].

Revue medicale de Bruxelles, 2000
When the term of the patent is completed, medicinal products may be copied. Generic products only refer to "essentially similar specialities". It means that bio-equivalence must be established. Generic medicines are cheaper than branded products involving a major economical issue.
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GENERIC DRUGS AND THERAPEUTIC EQUIVALENCE

JAMA: The Journal of the American Medical Association, 1968
In recent years, there has developed the belief that nonproprietary or generic drugs are much cheaper than, and as effective as, trade-named items. This belief has led to a widespread demand that prescribing and use of generic drugs be encouraged. Studies conducted by impartial groups such as the Medical Letter on Drugs and Therapeutics have applied ...
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Biosimilar Drugs Are Not Generics

Endocrine Practice, 2016
Farhad, Zangeneh, Richard, Dolinar
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