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 billion , without, for the most part, shorter development timelines.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

Drug Target Review

JULY 4, 2023

For instance, we can compare the data from the 2021 DESTINY gastric cancer trial using the ADC Trastuzumab Deruxtecan with data from a gastric cancer trial in 2004 using the small molecule Irinotecan. Antibody drug conjugated with cytotoxic payload. Translational and Clinical Pharmacology [Internet].

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40