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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]
Analytical and clinical chemistry testing. Safety testing data must be submitted to regulatory authorities for product marketing authorization. During the review process, the submitted data undergoes verification to ensure compliance with Good Laboratory Practice (GLP) standards.
A control chart is a more specific kind of run chart. The control chart is one of the seven basic tools of quality control, which also include the histogram, pareto chart, check sheet, cause and effect diagram, flowchart and scatter diagram. Control charts prevent unnecessary process adjustments, provide information about process capability ...
Therapeutic drug monitoring (TDM) is a branch of clinical chemistry and clinical pharmacology that specializes in the measurement of medication levels in blood.Its main focus is on drugs with a narrow therapeutic range, i.e. drugs that can easily be under- or overdosed. [1]
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
The first version of the standard was published in 2003, and it was revised in 2007 to align more closely to ISO/IEC 17025. [1] A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management.
These were addicts who wanted to stop using, or at least heard the message. They went to abstinence-based, military-themed rehabs and out-of-state Bible-themed rehabs. Some had led meetings or proselytized to addicts in church groups on the power of 12-step. They participated in 12-step study nights. One lived with his NA sponsor.
Clinical laboratories in the US that perform high complexity testing require a high complexity laboratory director (HCLD) that has earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.