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With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.
The first instrumental analysis was flame emissive spectrometry developed by Robert Bunsen and Gustav Kirchhoff who discovered rubidium (Rb) and caesium (Cs) in 1860. [4] Most of the major developments in analytical chemistry took place after 1900. During this period, instrumental analysis became progressively dominant in the field.
There are numerous variables that influence the interpretation of drug concentration data: time, route and dose of drug given, time of blood sampling, handling and storage conditions, precision and accuracy of the analytical method, validity of pharmacokinetic models and assumptions, co-medications and, last but not least, clinical status of ...
[1] [2] These methods can be categorized according to which aspects of the cell are controlled and which are measured. The three main categories are potentiometry (the difference in electrode potentials is measured), coulometry (the cell's current is measured over time), and voltammetry (the cell's current is measured while actively altering ...
In linear analysis, there is no test to falsify the assumption the is instrumental relative to the pair (,). This is not the case when X {\displaystyle X} is discrete. Pearl (2000) has shown that, for all f {\displaystyle f} and g {\displaystyle g} , the following constraint, called "Instrumental Inequality" must hold whenever Z {\displaystyle ...
An assay (analysis) is never an isolated process, as it must be accompanied with pre- and post-analytic procedures. Both the communication order (the request to perform an assay plus related information) and the handling of the specimen itself (the collecting, documenting, transporting, and processing done before beginning the assay) are pre-analytic steps.
Because of the complex inter-relationship between analytical method, sample concentration, limits of detection and method precision, the management of Analytical Quality Control is undertaken using a statistical approach to determine whether the results obtained lie within an acceptable statistical envelope.
Besides pharmaceutical applications chiral analysis [23] plays a major role in the study of biological and environmental samples and also in the forensic field. [24] Chiral analysis methods and applications between the period 2010 and 2020 are exhaustively reviewed recently. [25]