U.S. FDA Guidance for Industry—Potency Tests for Cellular and Gene Therapy Products, CDER January2011.
2.
U.S. FDA Draft Guidance—In Vitro Metabolism-and Transporter-Mediated Drug-Drug Interaction Studies, CDER October2017.
3.
U.S. FDA Guidance for Industry—Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, CDER December2017.
4.
EMA Guideline on the quality, nonclinical, and clinical aspects of gene therapy medicinal products, March2018.
LiJ. et al. Use of Transporter Knockdown Caco-2 Cells to Investigate the In Vitro Efflux of Statin Drugs. Drug Metab. Dispos. 2011; 39: 1196–1202.
8.
ZhangW. et al. Silencing the Breast Cancer Resistance Protein Expression and Function in Caco-2 Cells Using Lentiviral Vector-Based Short Hairpin RNA. Drug Metab. Dispos. 2009; 37: 737–744.
9.
DarnellM. et al. Investigation of the Involvement of P-Glycoprotein and Multidrug Resistance-Associated Protein 2 in the Efflux of Ximelagatran and Its Metabolites by Using Short Hairpin RNA Knockdown in Caco-2 Cells. Drug Metab. Dispos., 2009; 38: 491–497.
