On average, Chinese participants were older than their Caucasian counterparts (mean age 39.8 years vs
Charles ED, Neuschwander-Tetri BA, Pablo Frias J et al (2019) Pegbelfermin (BMS-986036), PEGylated FGF21, in Patients with Obesity and Type 2 Diabetes: Results from a Randomized Phase 2 Study
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Main Citation "Your firm failed to exercise appropriate controls over computer or related systems..." "The FDA identified a deficiency where the firm failed to perform a 'full audit trail review of production equipment.'" 15 "Lack of automated audit trails, allowing selective reporting of results." 16 Detailed Analysis of the Violation Production Equipment Audit Trails: The firm failed to perform a "full audit trail review of production equipment".15 In modern aseptic filling lines, the equipment is controlled by a Human Machine Interface (HMI) or Supervisory Control and Data Acquisition (SCADA) system
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Combination therapy was considered appropriate for adults with persistent kidney disease progression, high cardiovascular risk or suboptimal metabolic control
