Scientific judgement

Discussion of the following three examples, namely, general toxicology, cancer toxicology, and analytical chemistry will be used to illustrate the point. They have been selected because, among the life science-related disciplines, they cover the spectrum of needs for scientific "judgements. ... 

The first decision that must be taken when considering validation is whether the analyte should be quantified, or whether a limit test should be used. The latter involves significantly less validation and is recommended wherever possible. ICH Q2A requires only specificity and sensitivity for limit tests of impurities [81]. However, when one is considering trace impurities, scientific judgement... 

Weil, C.S. 1972. Statistics versus safety factors and scientific judgement in the evaluation for man. Toxicol. Appl. Pharmacol. 21 454-463. 

The purpose of hazard identification is to evaluate the weight of evidence for adverse effects in humans based on assessment of all available data, ranging from observations in humans and animal data to an analysis of mechanisms of action and structure-activity relationships. Each source of information has its advantages and limitations, which determine the weight of that evidence collectively, the evidence permits a scientific judgement as to whether the chemical can cause adverse effects. 

Determination of differences in results Sound scientific judgement, well thought out experiments and previous experience with the drug substance or product must be used to determine if an observed difference in degradation rates between samples is due to an actual difference in stability properties or whether the difference is within experimental error. Checking several containers of the same sample under the stress conditions can be used to establish the reproducibility of the observed degradation rate. This would include variability due to the individual samples and the... 

Each contribution is assessed as a standard uncertainty, either by statistical procedure on experimental data in the form of an a posteriori distribution, the so-called Type A evaluation, or by scientific judgement based on an a priori chosen distribution, Type B evaluation. The few standard uncertainties of important magnitude are combined quadraticahy, including any covariances, and the combined uncertainty, uc, is obtained as the positive square root. 

Biodegradation aqueous aerobic ty, = 168-672 h, based on scientific judgement aqueous anaerobic t,/j = 672-2688 h, based on unacclimated aqueous aerobic biodegradation half-life (Howard et al. 1991). Biotransformation ... 

The concept of uncertainty has already brought us to the second subject of the lecture we may take it as a scientific judgement of the value of the figures given by the toxicologists and often, of the opinion they have added as a conclusion to their figures. 

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