Biological essay (or “bioassay”), in its classical form, is concerned with the measurement of the concentration of an active ingredient in a test preparation, by estimation of its potency relative to that of a standard preparation. Assays, usually by animal experimentation, form an essential tool of biological standardization. Standard designs and methods of analysis are described here, including stochastic approximation, radioimmunoassays, semiparametric and nonparametric methods, and bioequivalence studies. In a broader sense, Bioassay refers to experiments, with biological units, to detect possible dose–response (or toxicity-adverse effect) relationships. Underlying toxicodynamics (and/or pharmacodynamics) and toxicokinetics (and/or pharmacokinetics), possibly in conjunction with toxicogenomics (and/or pharmacogenomics) may render such studies statistically quite different from conventional biometric studies. Some relevant approaches are considered here.


Keywords:

relative potency;
bioavailability;
bioequivalence;
dilution assay;
dosimetry;
PBPK;
TDTK;
toxicogenomics;
radioimmunoassay

Bioinformatics: statistical perspectives and controversies

Citations

Biological Assay, Overview

Biological Assay, Overview

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