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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.
A summation of relevant data and analysis from the protocol; An explanation of unexpected data and any other results not mandated by the protocol and its effects on production quality; Identify correlating effects and suggest changes to existing processes; Conclude if the process performance is adequately qualified to meet performance standards.
[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 ...
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The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
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.
The AUC (from zero to infinity) represents the total drug exposure across time. AUC is a useful metric when trying to determine whether two formulations of the same dose (for example a capsule and a tablet) result in equal amounts of tissue or plasma exposure. Another use is in the therapeutic drug monitoring of drugs with a narrow therapeutic ...