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Legal Control of Drugs and Generic Drugs
Nursing, Law & Ethics, 1980The 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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The Generic Inequivalence of Drugs
JAMA: The Journal of the American Medical Association, 1968Generic 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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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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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 Medical letter on drugs and therapeutics, 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 ...
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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 ...
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Drug discovery for a new generation of covalent drugs
Expert Opinion on Drug Discovery, 2012The 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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Confidence in Generic Drug Substitution
Clinical Pharmacology & Therapeutics, 2013Patients should have confidence that the generic drugs they are prescribed in the United States can be effectively substituted for the brand product or another generic product. Through new bioequivalence study designs for narrow therapeutic index (NTI) drugs and postapproval studies of generic substitution, the US Food and Drug Administration's (FDA's)
R, Lionberger +3 more
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AIDS policy & law, 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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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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Biosimilar Drugs Are Not Generics
Endocrine Practice, 2016Farhad, Zangeneh, Richard, Dolinar
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Antibody–Drug Conjugates: Smart Chemotherapy Delivery Across Tumor Histologies
Ca-A Cancer Journal for Clinicians, 2022Shanu Modi +2 more
exaly
Drug-Drug Interactions in General Anesthesia
Anesthesia & Analgesia, 1975C B, Drain, K L, Campman
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