article thumbnail

How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. This blog post will discuss how PK modeling can contribute to sample size estimation, a key aspect of a clinical trial protocol. Approaches to Pharmacokinetic Analysis.

article thumbnail

NRG announces £16m Series A for IND for Parkinson’s and ALS

pharmaphorum

Meanwhile, NRG’s in vitro studies have shown its INDs to protect mitochondria and increase the viability of human cells, potentially able to halt or significantly slow progression of diseases such as Parkinson’s and ALS. Currently, the treatments available only provide management of symptoms of chronic neurodegenerative disorders.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Kronos Bio Announces Publication of Preclinical Study Results for Investigational CDK9 Inhibitor KB-0742 in Cell Chemical Biology

The Pharma Data

Company is on t rack to s ubmit an IND in the fourth quarter of 2020 and i nitiate a Phase 1 /2 clinical trial for advanced solid tumors in 2021. We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D., SAN MATEO, Calif., and CAMBRIDGE, Mass.,

In-Vivo 40
article thumbnail

Clinical study first step towards treating respiratory syncytial virus 

Drug Discovery World

Enanta Pharmaceuticals, a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, has dosed the first subject in its Phase I clinical trial of EDP-323, a novel, oral L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). . The trial .

article thumbnail

Fibrosis research: Advances and challenges 

Drug Discovery World

Fibrocor is on track to complete all IND-enabling work to support IND filing and initiation of clinical trials in 2024. A second challenge is that the available lab models mainly mimic the early stages of the disease, whereas patients available for clinical trials present in more advanced stages.

article thumbnail

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).