RT Journal Article
SR Electronic
T1 Setting Specifications of Correlated Quality Attributes through Multivariate Statistical Modelling
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 533
OP 543
DO 10.5731/pdajpst.2013.00935
VO 67
IS 5
A1 Yang, Harry
YR 2013
UL http://journal.pda.org/content/67/5/533.abstract
AB Specifications of drug products are quality standards that provide assurance that the drug is fit for its intended use. Establishment of specifications limits relies on data collected during the life cycle of a product, including those from preclinical and clinical trials, stability studies, and process validation, and often requires application of appropriate statistical methods. While quality attributes may be correlated, specifications are often determined without taking into account possible interdependence. Such practice may potentially result in specifications that are narrower than acceptable ranges of product performance. Through a case study, this paper discusses how this issue can be coped with effectively by using multivariate statistical modelling. LAY ABSTRACT: Specifications of drug products are quality standards that provide assurance that the drug is fit for its intended use. Specifications are conventionally set up separately for each of the quality attributes of interest, without accounting for interdependence among the quality attributes. Such practice may potentially result in specifications that are narrower than acceptable ranges of product performance. Through a case study, this paper discusses how this issue can be coped with effectively by using statistical modelling.