Camargo
FEBRUARY 10, 2021
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.
The Pharma Data
MARCH 8, 2021
This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo. The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Camargo
DECEMBER 22, 2021
This is a key factor in designing Phase 2 and 3 trials. Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence. However, they may generate undifferentiated labels that are not conducive to commercial success.
The Pharma Data
OCTOBER 21, 2020
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.,
Pharmaceutical Technology
FEBRUARY 13, 2023
Best practice is to also consider the ‘developability’ of the lead compounds in conjunction with any evidence of potential in-vivo activity, by taking a holistic approach. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?
Camargo
SEPTEMBER 30, 2021
Nonclinical programs include (but are not limited to) method development and validation, pharmacokinetic studies, in vivo efficacy studies, safety pharmacology, IND-enabling toxicology studies, and long-term studies when appropriate. Overview of Drug Development Programs (Through IND Submission). Expensive starting materials.
Drug Discovery World
JANUARY 24, 2024
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.
Expert insights. Personalized for you.
133 
Let's personalize your content