Knowledge Corner

>>Knowledge Corner>>

Key Takeaways from The Bioprocessing Summit: Gene Therapy CMC and Analytics

Last week, at The Bioprocessing Summit in Boston’s Seaport district, we heard from industry leaders on their CMC and analytical strategies for developing gene therapy products. This was [...]

Clinical Probes and Endogenous Biomarkers as Substrates for Transporter Drug-Drug Interaction Evaluation

Perspectives From the International Transporter Consortium Introduction Transporter studies are performed at various stages of drug development ‒ discovery to first-in-human (FIH) phase (in-vitro substrate and inhibition [...]

2019-08-20T12:39:25-04:00August 20, 2019|Categories: AbsorbThis Blog, Drug Transporters|

Monitoring Oral Solid Dosage Forms Quality by NIR Spectroscopy and IDAS2

Monitoring Oral Solid Dosage Forms Quality by NIR Spectroscopy and IDAS2 Johayra Simithy1, Carlos Jiménez-Romero1, Anthony Severdia2, Daniel Álvarez3, Manuel Grosso1, Antonio Arias1, Nicole Spivey2, Jibin Li2,  Pablo [...]

Dabigatran Etexilate and Digoxin: Comparison as Clinical Probe Substrates for Evaluation of P-gp Inhibition

Introduction P-glycoprotein (P-gp) is a drug transporter recommended by regulatory agencies for in-vitro and in-vivo DDI evaluation. Due to high inter-laboratory variability in in-vitro P-gp data, regulators [...]

2019-07-18T15:00:45-04:00July 18, 2019|Categories: AbsorbThis Blog, Drug Transporters|Tags: , , |

Metformin Clinical DDI Study Design That Enables an Efficacy- and Safety-Based Dose Adjustment Decision

Introduction Metformin is an orally administered drug prescribed for the treatment of Type 2 diabetes. It is known to decrease hepatic glucose production, by inhibiting gluconeogenesis, and [...]