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A trough level is contrasted with a "peak level" (C max), which is the highest level of the medicine in the body, and the "average level", which is the mean level over time. It is widely used in clinical trials for newer medicines to investigate therapeutic effectiveness and safety.
Peak-to-trough ratio in pharmacokinetics is the ratio of peak (C max) and trough (C min) levels of a drug over its dosing interval (τ) at steady state.. Peak-to-trough ratio (PTR), also known as peak-to-trough variation or peak-to-trough fluctuation, is a parameter in pharmacokinetics which is defined as the ratio of C max (peak) concentration and C min (trough) concentration over a dosing ...
For instance, a regulatory agency (such as CE or FDA) may ensure that a product has been validated for general use before approval. An individual laboratory that introduces such an approved medical device may then not need to perform their own validation, but generally still need to perform verification to ensure that the device works correctly ...
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
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 ]
Single-use medical devices include any type of medical equipment, instrument, or apparatus that is disposed of after a single-use in a medical facility. The Food and Drug Administration defines this as any device entitled by its manufacturer that it is intended use is for one single patient and one procedure only. [ 1 ]
Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment ...