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.,

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In-Vivo In-Vitro Bioavailability Clinical Trials 40

The Pharma Data

NOVEMBER 19, 2020

These compounds have demonstrated high potency in inhibiting the activity of the M pro protease as well as promising oral bioavailability and blood plasma levels in animal studies. This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products.

Development 40

Development Bioavailability Production Drugs 40

The Pharma Data

DECEMBER 3, 2020

Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in Phase 3 development for the treatment of post-transplant patients with CMV in SOT or HSCT. 4, 2020 11:00 UTC. About Maribavir. Maribavir is an investigational treatment that has not been approved for use by the U.S. Forward-Looking Statements.

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Drugs Medicine Trials Containment 52

Drug Discovery World

OCTOBER 25, 2023

JV: A key bottleneck in the research and development of a drug is the lengthy experimentation that is required to gain the confidence to run clinical trials. MT: How does AI and ML accelerate the drug discovery process? Explainability and visibility into the “black box” of AI and ML technology is a significant challenge.

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Drugs Pharma Companies Clinical Trials Clinical Trials 111

Pharmaceutical Technology

NOVEMBER 24, 2022

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU. This has proved to be an extremely effective option for molecules where an understanding of absolute bioavailability is required.

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Bioavailability Manufacturing Drugs Production 130

Pharmaceutical Technology

AUGUST 3, 2022

If clinical trials prove successful, that same process should then be scaled to commercial manufacturing. Milling is a central part of powder processing, as this is where coarse particles are broken down into smaller ones for a variety of processability, bioavailability, reactivity, and safety-related reasons.

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Development Production Manufacturing Bioavailability 130

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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Trials Clinical Trials Clinical Trials Drugs 59