Controllable protocol factors

If there are known populations of people in whom drug disposition and effect differ, should we neglect enrolling them in clinical trials Certainly it is expedient to develop protocols that control for factors that may be a source of variability. However, in doing this, investigators must not systematically neglect important segments of the population. 

A number of input factors in CATD can be classified into two groups controllable factors and uncontrollable factors. Some major eontrollable ( protocol ) factors include ... 

The long history associated with the Hantzsch pyridine synthesis has produced numerous approaches and methods to the reaction protocol in order to control the various factors directing the course of the reaction. 

The number of subjects needed so that a study is likely to have an acceptable statistical power depends on a number of factors, including analytical parameters (precision, etc.), subject selection and control, and protocol design (cross-over, parallel). 

The ability to provide accurate and reliable data is central to the role of analytical chemists, not only in areas like the development and manufacture of drugs, food control or drinking water analysis, but also in the field of environmental chemistry, where there is an increasing need for certified laboratories (ISO 9000 standards). The quality of analytical data is a key factor in successfully identifying and monitoring contamination of environmental compartments. In this context, a large collection of methods applied to the routine analysis of prime environmental pollutants has been developed and validated, and adapted in nationally or internationally harmonised protocols (DIN, EPA). Information on method performance generally provides data on specificity, accuracy, precision (repeatability and reproducibility), limit of detection, sensitivity, applicability and practicability, as appropriate. 

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