State of Quality and Compliance in the Biopharmaceutical IndustryByIan Uydess,Anastasia G. LolasApril 1st 2013Have FDA initiatives improved manufacturing quality?
Regulatory Challenges in the QbD ParadigmByAnastasia G. Lolas,Anurag S. RathoreSeptember 1st 2012The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.