Excerpt from Practical Standardization by Chemical Assay of Organic Drugs and Galenicals
By standardization of a drug or medicinal preparation we mean bringing it to a definite strength as regards its medicinal activity. There are two ways in which this may be attempted. We may either make a direct trial of the effect produced by the medicine, administered under certain specified conditions, or we may ascertain if possible what is the active constituent of the drug, and then determine by assay the proportion of this constituent present in the sample under examination. The former method is empirical of course, but not on that account necessarily unscientific. The practical difficulty in endeavoring to apply it is that we have to deal with the reactions of a living organism to influences the nature of which is at best imperfectly understood. It is evident that we cannot hope to secure anything like identity in the conditions under which our experiments must be made, and the assumption that the reactions observed in a subject in normal health are not radically different from those under which drugs produce their therapeutic effects in illness is to say the least, a questionable one. Further it is obviously impracticable to employ the human subject in experiments of this character and the inferences deduced from experiments on the lower animals may easily be exceedingly misleading. Hence it is only to a very limited extent that the so-called biological method of assay is practised. The U. S. Pharmacopoeia gives it precognition, it is true, but in only one instance does it make a biological assay mandatory, and even in that instance offers a standard so vague that experts disagree widely in the results they report.
Standardization of any drug implies the possibility of a reasonably exact determination of its active constituent or constituents.
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