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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]
Reference ranges for blood tests are studied within the field of clinical chemistry (also known as "clinical biochemistry", "chemical pathology" or "pure blood chemistry"), the area of pathology that is generally concerned with analysis of bodily fluids.
The National Registry of Certified Chemists (NRCC) is an American certification agency for chemistry professionals founded in 1967. [ 1 ] In 1999, the organization name changed from National Registry in Clinical Chemistry to National Registry of Certified Chemists to reflect the broader scope of chemists.
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]
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.
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]
Testing Ames test – salmonella bacteria is exposed to a chemical under question (a food additive, for example), and changes in the way the bacteria grows are measured.. This test is useful for screening chemicals to see if they mutate the structure of DNA and by extension identifying their potential to cause cancer in hu
The safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain equivalent throughout their lifecycle. [ 18 ] [ 19 ] Process variations are monitored by modern analytical tools (e.g., liquid chromatography , immunoassays , mass spectrometry , etc.) and describe a unique design space for each biologic.