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A pragmatic approach for the adoption of QbD principles for analytical method development and validation

18 April 2013 | By Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG

The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the…

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Boehringer Ingelheim and Lilly initiate MARLINA™ clinical trial to evaluate use of Trajenta® (linagliptin) in patients with type 2 diabetes and albuminuria

19 March 2013 | By Boehringer Ingelheim

Boehringer Ingelheim and Eli Lilly and Company announced today the initiation of a Phase IIIb trial to evaluate the glycaemic efficacy and safety of linagliptin in type 2 diabetes patients with prevalent albuminuria, and urinary albumin-to-creatinine (UACR) ratio 30-3000 mg/g creatinine, in addition to current standard therapy for diabetic nephropathy.…