Abstract
Parallelism testing between two four-parameter logistic curves has been widely discussed over the last decade. Current tests available in common statistical software used in laboratories have been shown to be highly flawed. In 2012, Yang et al. showed an easy way to implement an intersection union test based on confidence intervals on ratios of parameters of both curves. The method was automated using a fully good manufacturing practice–compliant software package. Although the rationale is correct and efficient, a small mistake appears in the computation of the confidence intervals in the paper and may lead to error when implementing the intersection union test in a software package. Because parallelism testing is both a prerequisite for the determination of relative potency of bioassays and a regulatory requirement, it is important to rectify this mistake. In this paper, we show the actual formulas to be used to compute confidence interval on ratios of parameters.
- © PDA, Inc. 2015
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.