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Author: Dr. Pallavi Limaye
Blog Dr. Pallavi Limaye
New FDA Draft Guidance “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics” – XenoTech’s perspective on in vitro DDI testing
- Regulatory Guidance
- July 11, 2022
- Dr. Maciej Czerwinski, Dr. Pallavi Limaye, Dr. Brian Ogilvie
The FDA has released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”...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
- Drug Drug Interactions (DDI)
- August 12, 2020
- Madison Esely-Kohlman, Dr. Pallavi Limaye, Andrea Wolff, Dr. Maciej Czerwinski
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
- In Vivo & Radiolabeling
- August 6, 2020
- Madison Esely-Kohlman, Jolanta Golec, Dr. Pallavi Limaye
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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