[BOOK][B] Emerging non-clinical biostatistics in biopharmaceutical development and manufacturing
H Yang - 2016 - taylorfrancis.com
The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product
should be based upon a thorough understanding of both the product and the manufacturing …
should be based upon a thorough understanding of both the product and the manufacturing …
Implementation of parallelism testing for four-parameter logistic model in bioassays
H Yang, HJ Kim, L Zhang, RJ Strouse… - PDA journal of …, 2012 - journal.pda.org
Parallelism is a prerequisite for the determination of relative potency in bioactivity assays. It
involves the testing of similarity between a pair of dose-response curves of reference …
involves the testing of similarity between a pair of dose-response curves of reference …
Validation of qualitative microbiological test methods
PC IJzerman‐Boon… - Pharmaceutical …, 2015 - Wiley Online Library
This paper considers a statistical model for the detection mechanism of qualitative
microbiological test methods with a parameter for the detection proportion (the probability to …
microbiological test methods with a parameter for the detection proportion (the probability to …
[PDF][PDF] Implementation of Parallelism Testing for Four-Parameter
H Yang, HJ Kim, L Zhang - community.jmp.com
Parallelism is a prerequisite for the determination of relative potency in bioactivity assays. It
involves the testing of similarity between a pair of dose-response curves of reference …
involves the testing of similarity between a pair of dose-response curves of reference …