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U.S. Army Public Health Center Toxicology Lab technician assessing samples. Toxicology testing, also known as safety assessment, or toxicity testing, is the process of determining the degree to which a substance of interest negatively impacts the normal biological functions of an organism, given a certain exposure duration, route of exposure, and substance concentration.
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]
Clinical pathology is a medical specialty that is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids, such as blood, urine, and tissue homogenates or extracts using the tools of chemistry, microbiology, hematology, molecular pathology, and Immunohaematology.
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]
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)
Pharmacology can be applied within clinical sciences. Clinical pharmacology is the application of pharmacological methods and principles in the study of drugs in humans. [21] An example of this is posology, which is the study of dosage of medicines. [22] Pharmacology is closely related to toxicology.
IUPAC made a recommendation in 1991 [1] for the description and measurement of carryover effects in clinical chemistry. The carryover ratio is the percentage of H3 carry to L1 constituting the carryover portion "h". In a design of 3 high samples followed by 3 low samples, h can be calculated as (L1 - mean of L2&L3) / (H3 - mean of L2&L3)
A pharmacogenomics test later proved the patient had a CYP2D6 *1/*41, which has a predicted phenotype of IM and CYP2C19 *1/*2 with a predicted phenotype of IM as well. Case B – Pain Management [46] Patient B is a woman who gave birth by caesarian section. Her physician prescribed codeine for post-caesarian pain.