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In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
The Nottingham prognostic index (NPI) is used to determine prognosis following surgery for breast cancer. [1] [2] Its value is calculated using three pathological criteria: the size of the tumour; the number of involved lymph nodes; and the grade of the tumour. [1] It is calculated to select patients for adjuvant treatment.
Similarly, "disease-free survival" is the length of time after patients have received treatment and have no detectable disease. Time to progression (TTP) does not count patients who die from other causes but is otherwise a close equivalent to PFS (unless there are many such events). [2] The FDA gives separate definitions and prefers PFS. [3]
Staging breast cancer is the initial step to help physicians determine the most appropriate course of treatment. As of 2016, guidelines incorporated biologic factors, such as tumor grade, cellular proliferation rate, estrogen and progesterone receptor expression, human epidermal growth factor 2 (HER2) expression, and gene expression profiling into the staging system.
The majority of drugs used in cancer chemotherapy are cytostatic, many via cytotoxicity. A fundamental philosophy of medical oncology , including combination chemotherapy, is that different drugs work through different mechanisms, and that the results of using multiple drugs will be synergistic to some extent.
The area of each square is proportional to the study's weight in the meta-analysis. The overall meta-analysed measure of effect is often represented on the plot as a dashed vertical line. This meta-analysed measure of effect is commonly plotted as a diamond, the lateral points of which indicate confidence intervals for this estimate.
To ensure that the drug taker who has poor absorption is dosed appropriately, the bottom value of the deviation range is employed to represent real bioavailability and to calculate the drug dose needed for the drug taker to achieve systemic concentrations similar to the intravenous formulation. [4]
Also, DVHs from initial radiotherapy plans represent the doses to structures at the start of radiation treatment. As treatment progresses and time elapses, if there are changes (i.e. if patients lose weight, if tumors shrink, if organs change shape, etc.), the original DVH loses its accuracy. [10]
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