Author: Dr. Pallavi Limaye
New FDA Draft Guidance “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics” – XenoTech’s perspective on in vitro DDI testing
The FDA has released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”...
Drug-Drug Interaction (DDI) Prediction Models Following In Vitro Studies in Preclinical Development
In preclinical development, a drug will be evaluated for potential to cause a drug-drug interaction (DDI) using in vitro experiments and then calculations that...
Toxicokinetic (TK) Analysis for Preclinical Drug Development
The main goal of preclinical toxicokinetic (TK) studies is to establish a correlation between a candidate compound’s concentration or dose...
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