Drug Target Review

JULY 4, 2023

Improving efficacy with ADCs The widely quoted notion that ADCs increase the therapeutic window by lowering the minimum effective dose (MED) and increasing the maximum tolerated dose (MTD) is not supported by clinical data from human studies, indicating the MTD of ADCs is not significantly different from small molecules.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

Alta Sciences

MAY 15, 2023

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 And integration with our CDMO ensures the clinical trial drug product is available on time.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40