Drug Target Review

APRIL 7, 2025

4 The definition has since evolved and expanded to include molecular signatures of pharmacodynamics and therapeutic response. Novel mechanisms of action associated with CGTs naturally create dosing effects that apply in very different ways than with traditional small molecule pharmacotherapies. 21(10):3517. Rodrigues AD.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

DrugBaron

FEBRUARY 7, 2022

Finding small molecule drugs is much harder than finding a needle in a haystack – discovering the right arrangement of atoms to bind precisely to a protein target to elicit a particular response is a problem of vast dimensionality. Yet the situation with small molecules is even worse.

Small Molecule 100

Small Molecule Synthetic Chemistry Pharma Companies Pharmacokinetics 100

Practical Cheminformatics

JANUARY 8, 2024

When given the prompt “Please estimate the binding affinity between the drug Afatinib and target EGFR”, GPT-4 suggested a docking study, which is definitely not a wise choice. These fingerprint bits then map to atom environments or bond paths, which often don’t correspond to widely accepted functional group definitions.

Drugs 136

Drugs Small Molecule Bioinformatics Packaging 136

The Pharma Data

AUGUST 21, 2020

Novartis has agreed to contribute a carefully curated library of about 1300 small molecules with antiviral activity to the CARE project. We are also supporting the consortium’s preclinical safety and pharmacokinetics workstreams. I guess that’s the true definition of situational leadership.

Virus 52

Virus Small Molecule Licensing Licensing 52

Agency IQ

JULY 26, 2024

in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products. Any CMC changes (e.g.,

Biosimilars 40

Biosimilars Science FDA Production 40

Agency IQ

JUNE 9, 2023

However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs. It also contains a definition of the term immunotoxicity— the unintended immunosuppression or stimulation (including hypersensitivity) —which was notably absent from the draft.

FDA 40

FDA Science Small Molecule Immune Response 40

Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Just a few months ago, OCE Associate Director HARPREET SINGH noted , “I know definitely for older adults… there’s not enough work done.”

FDA 40

FDA Science Clinical Trials Trials 40