Validation content

It is recommended that the protocol be divided into three major sections Section I, which discusses the background and validation methodology Section II, which contains areas in which data collected during validation can be documented and Section III, a section for the various attachments that will be involved. It should be understood that the contents of these sections may reside in validation-specific SOPs. Even if appropriate SOPs have been created, however, there is no assurance that the statements will be reflected in the execution of the validation. Contents of each of these three sections are discussed in the following sections of this chapter. 

Gilham E, Kuzniecky R, Eaught E, et al. Patient-validated content of epilepsy-specific quahty-of-hfe measurement. Epilepsia 1997 38 233-236. 

Chemical education researchers are typically asked to demonstrate that the test instruments used in their studies are valid and reliable. Validity is the extent to which a question measures what it purports to measure. There are several forms of validity (face validity, content validity, construct validity, etc.), and different forms become relevant for different test instruments. Reliability, on the other hand, is the extent to which the question is stable over time, i.e., if the instrument were administered to similar groups of students at two different times. 

Validity relates to whether you are measuring what you want to measure. When we measure the width of a room, the question of validity usually does not arise. When we are measuring a complex process, such as aptitude to perform well in college or the ability of the safety-management system in a plant to prevent future loss, validity becomes a serious question. Scientists (Chronbach and Meeh 1955) generally define three categories of validity content-related, criterion-related, and construct-related validity. 

Biological infonnation is also concerned witli tire analysis of biological messages and tlieir import. The fundamental premise of tire protein-folding problem section C2.14.2.2 is tliat tire full tliree-dimensional arrangement of tire protein molecule can be predicted, given only tire amino acid sequence, together witli tire solvent composition, temperature and pressure. One test of tire validity of tliis premise is to compare tire infonnation content of tire sequence witli tire infonnation contained in tire stmcture [169]. The fonner can be obtained from Shannon s fonnula ... 

Oui recommendation is that one should use n-leave-out cross-validation, rather than one-leave-out. Nevertheless, there is a possibility that test sets derived thus would be incompatible with the training sets with respect to information content, i.e., the test sets could well be outside the modeling space [8]. 

The electrolytes used were acetate buffer at pEI values 2, 4 and 6 and the same electrolyte is used in the presence of EDTA at pEI values of 2 and 6. Iron and copper contents could be most easily determined in EDTA medium at pH 6. The best medium for nickel was found to be as ammonia buffer pH 9.5 qg/L, it could be separated from zinc in this medium. The elements determined in white and red wine were Cu, Pb, Zn, Cd, Fe and Ni. The quantities found were for iron about 9000 qg/L, for copper 290 qg/L, Ni 80 qg/L, lead 150 qg/L and zinc 460 qg/L. The validation was made by determining each element under different conditions. 

VALIDATED HPTLC DETERMINATION AND CONTENT UNIFORMITY TEST FOR ALPRAZOLAM AND MELATONINE IN TABLET DOSAGE FORM... 

Because the rates of chemical reactions are controlled by the free energy of the transition state, information about the stmcture of transition states is crucial to understanding reaction mechanism. However, because transition states have only transitory existence, it is not possible to make experimental measurements that provide direct information about their structure.. Hammond has discussed the circumstances under which it is valid to relate transition-state stmcture to the stmcture of reactants, intermediates, and products. His statements concerning transition-state stmcture are known as Hammond s postulate. Discussing individual steps in a reaction mechanism, Hammond s postulate states if two states, as, for example, a transition state and an unstable intermediate, occur consecutively during a reaction process and have neariy the same energy content, their interconversion will involve only a small reorganization of molecular stmcture. ... 

Process validation should be extended to those steps determined to be critical to the quality and purity of the enantiopure drug. Establishing impurity profiles is an important aspect of process validation. One should consider chemical purity, enantiomeric excess by quantitative assays for impurity profiles, physical characteristics such as particle size, polymorphic forms, moisture and solvent content, and homogeneity. In principle, the SMB process validation should provide conclusive evidence that the levels of contaminants (chemical impurities, enantioenrichment of unwanted enantiomer) is reduced as processing proceeds during the purification process. 

Enthalpy is a type of chemical energy, sometimes referred to as heat content Reactions that occur in the laboratory in an open container or in the world around us take place at a constant pressure, that of the atmosphere. For such reactions, the equation just written is valid, making enthalpy a very useful quantity. 

The content of a curriculum must be functional when dealing with societal activities necessary chemical concepts, skills and attitudes with respect to macro-micro thinking must be included. This can be derived from representative authentic tasks. The content of the curriculum should be considered as a chemical toolbox. The traditional content of the present chemistry curriculum, such as the stmcture of atoms, ionic theoiy, fundamental acid-base calculations, are not necessarily part of the chemical toolbox when addressing chemical and technological tasks. The validity of the toolbox (philosophical substmcture) is determined by the representative practices and tasks related to chemistry (cf need-to-know principle in context-based approaches). 

Philosophical substructure, the argumentation about how content is defined as valid and applicable in chemically relevant social (communities of) practice ... 

Subcase b2 This case, called the paired f-test , is often done when two test procedures, such as methods A and B, are applied to the same samples, for instance when validating a proposed procedure with respect to the accepted one. In practicular, an official content uniformity" 5 assay might prescribe a photometric measurement (extract the active principle from a tablet... 

Situation During the introduction of a new tablet manufacturing process, the operation of a conditioner had to be validated the function of this conditioner is to bring the loaded tablets to a certain moisture content for further processing. 

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