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Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration.

08:00 EDT 2nd October 2019 | BioPortfolio

Summary of "Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration."

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This article was published in the following journal.

Name: JAMA network open
ISSN: 2574-3805
Pages: e1913029

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Medical and Biotech [MESH] Definitions

Diminished or failed response of an organism, disease or tissue to the intended effectiveness of a chemical or drug. It should be differentiated from DRUG TOLERANCE which is the progressive diminution of the susceptibility of a human or animal to the effects of a drug, as a result of continued administration.

Administration of low doses of a drug or a drug combination over prolonged periods of time usually at a regular interval.

Progressive diminution of the susceptibility of a human or animal to the effects of a drug, resulting from its continued administration. It should be differentiated from DRUG RESISTANCE wherein an organism, disease, or tissue fails to respond to the intended effectiveness of a chemical or drug. It should also be differentiated from MAXIMUM TOLERATED DOSE and NO-OBSERVED-ADVERSE-EFFECT LEVEL.

Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.

Strategies required by the US Food and Drug Administration (FDA) Amendments Act of 2007 when a question exists as to whether the benefits of a drug outweigh its risks. These constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients.

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