Documented tests and real world experience with a large amount of data show that the technique is flexible, easily understood and applicable in a broad range of applications.
First flight claims are made for Ader, Whitehead, Richard Pearse, and Karl Jatho for their variously documented tests in years prior to and including 1903.
Further, the documented test indication, such as a prior diagnosis of adenoma or family history of CRC, guides clinicians in making follow-up recommendations [ 1, 16, 17].
The documented tests were leucocytes, platelet, percentage of neutrophils, absolute neutrophils count (ANC), Aspartate Transaminase (AST), Alanine Transaminase (ALT) and total and direct bilirubin.
Therefore, NCDFA is required in all regulated studies to verify the documented test article concentrations in formulations used to calculate these safety margins (1, 2).
With respect to tests of renal function, which included creatinine, 81% of cases had one or more documented tests in the last year, thereby meeting the QOF standard, while 55% had two or more documented tests and therefore met the NICE standard.
With respect to lithium serum levels, 68% of cases had 2 or more documented tests in the previous year, thus meeting the QOF standard, while 30% had 4 or more tests in the last year, reaching the NICE standard.
Therefore, nonclinical dose formulation analysis (NCDFA) is required in all nonclinical regulated studies to verify the documented test article concentrations in formulations used to determine these safety margins (1– 3).
In another study, this one of primary care ambulatory practices, clinicians documented test results were missing, often causing clinical delay, for one out of ten patients in clinic [ 15].
