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PDA Journal of Pharmaceutical Science and Technology|December 15, 2015
A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total ErrorHarry Yang, Jianchun ZhangPDA Journal of Pharmaceutical Science and Technology|October 3, 2015
Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology ProductsKim Li, Gary Rogers, Yasser Nashed-Samuel, et al.PDA Journal of Pharmaceutical Science and Technology|October 3, 2015
Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma SuppliersCarles Parés, Manuel Martínez, Joaquim Messeguer, et al.PDA Journal of Pharmaceutical Science and Technology|September 5, 2014
Advice on Degradation Products in Pharmaceuticals: A Toxicological EvaluationSâmia Rocha de Oliveira Melo, Maurício Homem-de-Mello, Dâmaris Silveira, et al.PDA Journal of Pharmaceutical Science and Technology|December 6, 2014
Preliminary Evaluation of Next-Generation Sequencing Performance Relative to qPCR and In Vitro Cell Culture Tests for Human CytomegalovirusSiemon H S Ng, Ali Azizi, Kerrie Edamura, et al.PDA Journal of Pharmaceutical Science and Technology|December 6, 2014
Defining a sample preparation workflow for advanced virus detection and understanding sensitivity by next-generation sequencingChristopher J Wang, Szi Fei Feng, Paul DuncanPDA Journal of Pharmaceutical Science and Technology|December 6, 2014
Bacterial genome reference databases: progress and challengesTom SlezakPDA Journal of Pharmaceutical Science and Technology|December 6, 2014
FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing TechnologiesCarolyn A Wilson, Vahan SimonyanPDA Journal of Pharmaceutical Science and Technology|December 6, 2014
Whole genome: next-generation sequencing as a virus safety test for biotechnological productsEric Cabannes, Charles Hébert, Marc EloitPDA Journal of Pharmaceutical Science and Technology|December 6, 2014
Evaluation of a549 as a new vaccine cell substrate: digging deeper with massively parallel sequencingPaul Shabram, John L KolmanPageof 136