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A clinical chemistry analyzer; hand shows size. Clinical chemistry (also known as chemical pathology, clinical biochemistry or medical biochemistry) is a division in medical laboratory sciences focusing on qualitative tests of important compounds, referred to as analytes or markers, in bodily fluids and tissues using analytical techniques and specialized instruments. [1]
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
Case series have a descriptive study design; unlike studies that employ an analytic design (e.g. cohort studies, case-control studies or randomized controlled trials), case series do not, in themselves, involve hypothesis testing to look for evidence of cause and effect (though case-only analyses are sometimes performed in genetic epidemiology ...
The terms clinical trial and clinical study are synonymous. (ICH E6) Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. (ICH E6)
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
The PICO process (or framework) is a mnemonic used in evidence-based practice (and specifically evidence-based medicine) to frame and answer a clinical or health care related question, [1] though it is also argued that PICO "can be used universally for every scientific endeavour in any discipline with all study designs". [2]
Multiple choice questions lend themselves to the development of objective assessment items, but without author training, questions can be subjective in nature. Because this style of test does not require a teacher to interpret answers, test-takers are graded purely on their selections, creating a lower likelihood of teacher bias in the results. [8]
In clinical pharmaceutical chemistry the aim is to understand biological transformations and processes associated with chemical entities inside the human body, and how those processes can be influenced with changes in chemical structures.