Analytical Procedure Validation and the Quality by Design Paradigm

Analytical procedure validation and the quality by design paradigm.

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a similar approach. While development and optimization of analytical procedure following QbD principles have been largely discussed and described, the pla...

Validation of an Analytical Procedure

Antibiotics Residues in Honey: Validation Procedure Honey Analytical Methods Validation

An uncontrolled used of antibiotics and sulphonamides is responsible for the presence of residues in beehive products and contributes to the problem of food safety. The optimisation of analytical methods for the detection of residues of antibacterial drugs (sulphonamides, SPs; tylosin, TL; streptomycin, ST) in honey was pursued and the methods applied to routine samples. ST was investigated by ...

construction and validation of translation metacognitive strategy questionnaire and its application to translation quality

like any other learning activity, translation is a problem solving activity which involves executing parallel cognitive processes. the ability to think about these higher processes, plan, organize, monitor and evaluate the most influential executive cognitive processes is what flavell (1975) called “metacognition” which encompasses raising awareness of mental processes as well as using effectiv...

the investigation of the relationship between type a and type b personalities and quality of translation

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