Camargo

SEPTEMBER 30, 2021

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. This blog post offers advice for avoiding major pitfalls during the drug development process. Overview of a Drug Development Program. Take a look.

Development 201

Development Research Manufacturing In-Vivo 201

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. Proper planning of PK assessments can accelerate the development of both novel drugs and new formulations of previously approved drugs developed via the 505(b)(2) pathway.

Production 133

Production Bioavailability In-Vivo Bioequivalency 133

Camargo

DECEMBER 22, 2021

Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Clinical Pharmacology. Clinical Safety and Efficacy.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

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

Trials 69

Trials In-Vivo Genotoxicity RNA 69

Pharmaceutical Technology

FEBRUARY 13, 2023

The continued high level of interest in small molecules presents multiple opportunities to select a candidate that is ‘developable’, with subsequent rapid progression toward first-in-human (FIH) clinical testing. Therefore, it is vital to choose molecules for pharmaceutical development very carefully.

Development 130

Development In-Vivo Clinical Trials Clinical Trials 130

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.,

In-Vivo 40

In-Vivo In-Vitro Bioavailability Clinical Trials 40

Drug Discovery World

JANUARY 24, 2024

Fibrocor Therapeutics, a developer of novel therapeutics to treat fibrosis, recently appointed Piet Wigerinck as Chief Scientific Advisor. Fibrocor is on track to complete all IND-enabling work to support IND filing and initiation of clinical trials in 2024.

Research 59

Research Gene Expression Drugs Development 59