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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 ...
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 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.
Proliferation, as one of the hallmarks and most fundamental biological processes in tumors, [1] is associated with tumor progression, response to therapy, and cancer patient survival. [2] Consequently, the evaluation of a tumor proliferative index (or growth fraction) has clinical significance in characterizing many solid tumors and hematologic ...
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.
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]
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