<span>Evaluation of a cost-effective in vitro human model for predicting intrinsic hepatocyte clearance of slowly metabolized compounds</span>
September 10, 2023

Evaluation of a cost-effective in vitro human model for predicting intrinsic hepatocyte clearance of slowly metabolized compounds

ISSX NA 2023 -- In vitro models play key roles in drug discovery, allowing for the prediction of in vivo metabolism and pharmacokinetics (DMPK) parameters while minimizing cost and maximizing throughput. Primary human hepatocytes (PHH) are often used as a liver model to predict metabolic stability and intrinsic clearance (CLint) of new drug compounds.
Read more »
<span>ICH Q14 101: Applying AQbD to CMC for Regulatory Success</span>
September 27, 2023

ICH Q14 101: Applying AQbD to CMC for Regulatory Success

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q14 is a new quality document describing analytical procedure development. Previously, no ICH guidance specifically covered analytical method development, resulting in a lack of clarity on what to present to regulators.

Read more »
<span>Labcorp Biopharmaceutical CMC Analytical Development Services</span>
September 27, 2023

Labcorp Biopharmaceutical CMC Analytical Development Services

The underlying principle for biopharmaceutical development and manufacturing is to provide a drug product that is both safe and efficacious for the patient. Therefore, manufacturing of any drug substance and drug product must demonstrate consistent production of a quality product, which must be shown to be stable over its intended shelf life.

Read more »