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In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
A test panel is a predetermined group of medical tests used in the diagnosis and treatment of disease.. Test panels (sometimes called profiles) are typically composed of individual laboratory tests which are related in some way: by the medical condition they are intended to help diagnose (cardiac risk panel), by the specimen type (complete blood count, CBC), by the tests most frequently ...
A drug test (also often toxicology screen or tox screen) is a technical analysis of a biological specimen, for example urine, hair, blood, breath, sweat, or oral fluid/saliva—to determine the presence or absence of specified parent drugs or their metabolites.
The Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed in the USA subsequent to the publication of an article in November 1987 in The Wall Street Journal entitled "Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Labs Errors", which alerted the public to the fact that a pap smear may be falsely negative.
Chemistry Research Laboratory, University of Oxford, the main chemistry building at Oxford University Complete Response Letter , the official FDA response to a New Drug Application Crown-rump length , the ultrasound measurement of a foetus
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 drug has been found to block the dopamine transporter (DAT) by 83%, to a greater extent than methylphenidate without unfavorable concomitant adrenergic effects. [8] The drug is an atypical DRI similarly to modafinil. [11] [1] [9] The affinities for the DAT of flmodafinil's enantiomers and modafinil have also been studied.
A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.