JSM 2004 - Toronto

Abstract #301084

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Activity Number: 305
Type: Contributed
Date/Time: Wednesday, August 11, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301084
Title: Comparative Dilution Bioassays: Parallel Line Approach vs. Converting through Standard Curve
Author(s): Charles Y. Tan*+
Companies: Merck & Co., Inc.
Address: PO Box 4, West Point, PA, 19486,
Keywords: parallel line assay ; bioassay ; relative potency
Abstract:

The biological activity or potency of a complex material is usually measured by dilution assays in which the biochemical responses of the test material are compared to those of a standard material at several dilution levels. A parallel line approach derives the relative potency from the "shift" between the two dilution-response curves. The potency of the test material is simply the relative potency times the known (or nominal) potency of the standard. Another common approach is to convert the responses of the test material through a standard curve (potency-response), adjust the estimated potencies by their dilution factors and then average. The statistical and scientific advantages of the parallel line approach will be argued. Statistical advantages will be detailed for the linear response curve case. Results will be extended to the four-parameter logistic response curve case.

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