A novel method for qualification of a potency assay through partial computer simulation
For biotherapeutics and vaccines, potency is measured in a bioassay that compares the
concentration-response curves of a new batch to that of a reference standard. Acceptable …
concentration-response curves of a new batch to that of a reference standard. Acceptable …
Using computer simulated results of a bulk drug substance assay to determine acceptance criteria for method validation
RD Bunnell - Pharmaceutical research, 1997 - Springer
Purpose. To determine the statistical variability expected for a well designed HPLC assay of
a bulk drug substance (BDS). The results are used to develop appropriate acceptance …
a bulk drug substance (BDS). The results are used to develop appropriate acceptance …
Selecting an appropriate dose-response curve in bioassay development
JJZ Liao, F Duan, Y Meng, Q Zhao - Frontiers in Drug Design and …, 2010 - books.google.com
Bioassay or biological assay is a type of in vitro experiment that is typically conducted to
measure the effect or activity of a substance or stimulus in a biological system, for estimating …
measure the effect or activity of a substance or stimulus in a biological system, for estimating …
A Bayesian statistical approach to continuous qualification of a bioassay
SJ Novick, E Christian, E Farmer… - PDA Journal of …, 2021 - journal.pda.org
A validated bioassay is used to measure the potency of commercial lots, and as such, must
be accurate, precise, and fit for its intended purpose. Regulatory expectations for a bioassay …
be accurate, precise, and fit for its intended purpose. Regulatory expectations for a bioassay …
Assay validation
Recently, the lifecycle management concept for analytical procedures was introduced. It is
strongly related to the Quality by Design concept given in the ICH-Q8 guidance. This …
strongly related to the Quality by Design concept given in the ICH-Q8 guidance. This …
A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays
R Li, W Cai, M Zocher - PDA Journal of Pharmaceutical Science …, 2017 - journal.pda.org
Bioassay data analysis is used to determine the potency of protein therapeutics. To properly
determine potency, the experimental data need to be fitted to a model that adequately …
determine potency, the experimental data need to be fitted to a model that adequately …
Methods for the Design and Analysis of Replicate‐Experiment Studies to Establish Assay Reproducibility and the Equivalence of Two Potency Assays
BJ Eastwood, AK Chesterfield… - Pharmaceutical …, 2010 - Wiley Online Library
Statistical parameters estimated in validation studies to establish the reliability of single‐
concentration assays, such as the Signal Window and Z'‐Factor, are well established. These …
concentration assays, such as the Signal Window and Z'‐Factor, are well established. These …
A Bayesian approach to show assay equivalence with replicate measurements over a specified response range
S Novick, K Chiswell, J Peterson - Statistics in Biopharmaceutical …, 2012 - Taylor & Francis
Drug discovery scientists routinely develop and use in-vitro assays; for example, to identify
“hits,” or to quantify the efficacious concentrations of compounds in a lead series. New and …
“hits,” or to quantify the efficacious concentrations of compounds in a lead series. New and …
Principles of vaccine potency assays
T Verch, JJ Trausch, M Shank-Retzlaff - Bioanalysis, 2018 - Future Science
Compared with biologics, vaccine potency assays represent a special challenge due to their
unique compositions, multivalency, long life cycles and global distribution. Historically …
unique compositions, multivalency, long life cycles and global distribution. Historically …
Analytical considerations to support expeditious formulation development of vaccines
P Kumar, V Agrahari - Bioanalysis, 2023 - Future Science
Vaccine potency assays pose a unique challenge due to the inherent structural complexity,
multivalent composition, long shelf-life and global distribution of vaccines [1]. Potency …
multivalent composition, long shelf-life and global distribution of vaccines [1]. Potency …