FDA Approves Two New Indications and Dosage Form for Pembrolizumab.

08:00 EDT 14th May 2019 | BioPortfolio

Summary of "FDA Approves Two New Indications and Dosage Form for Pembrolizumab."

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Name: Oncology (Williston Park, N.Y.)
ISSN: 0890-9091


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Medical and Biotech [MESH] Definitions

Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.

The number of copies of a given gene present in the cell of an organism. An increase in gene dosage (by GENE DUPLICATION for example) can result in higher levels of gene product formation. GENE DOSAGE COMPENSATION mechanisms result in adjustments to the level GENE EXPRESSION when there are changes or differences in gene dosage.

Genetic mechanisms that allow GENES to be expressed at a similar level irrespective of their GENE DOSAGE. This term is usually used in discussing genes that lie on the SEX CHROMOSOMES. Because the sex chromosomes are only partially homologous, there is a different copy number, i.e., dosage, of these genes in males vs. females. In DROSOPHILA, dosage compensation is accomplished by hypertranscription of genes located on the X CHROMOSOME. In mammals, dosage compensation of X chromosome genes is accomplished by random X CHROMOSOME INACTIVATION of one of the two X chromosomes in the female.

The highest dosage administered that does not produce toxic effects. The NOAEL will depend on how closely dosages are spaced (lowest-observed-adverse-effect level and no-observed-effect level) and the number of animals examined. The ultimate objective is usually to determine not the "safe" dosage in laboratory animals but the "safe" dosage for humans. Therefore, the extrapolation most often required of toxicologists is from high-dosage studies in laboratory animals to low doses in humans. (Casarett and Doull's Toxicology: The Basic Science of Poisons, 4th ed)

The amount of radiation energy that is deposited in a unit mass of material, such as tissues of plants or animal. In RADIOTHERAPY, radiation dosage is expressed in gray units (Gy). In RADIOLOGIC HEALTH, the dosage is expressed by the product of absorbed dose (Gy) and quality factor (a function of linear energy transfer), and is called radiation dose equivalent in sievert units (Sv).

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