The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.
A regulatory viewpoint on transporter-based drug interactions
Abstract
1. Pharmacokinetic drug interactions can lead to serious adverse events and the evaluation of a new molecular entity's (NME) drug-drug interaction potential is an integral part of drug development and regulatory review before its market approval. Clinically relevant interactions mediated by transporters are of increasing interest in clinical development and research in this emerging area and it has been revealed that drug transporters can play an important role in modulating drug absorption, distribution, metabolism and elimination. 2. Acting alone or in concert with drug-metabolizing enzymes transporters can affect the pharmacokinetics and/or pharmacodynamics of a drug. The newly released drug interaction guidance by the US Food and Drug Administration (USFDA) includes new information addressing drug transporter interactions with a primary focus on P-glycoprotein (P-gp, ABCB1). 3. This paper provides a regulatory viewpoint on transporters and their potential role in drug-drug interactions. It first outlines information that might be needed during drug development and ultimately included in new drug application (NDA) submissions to address potential transporter-mediated drug interactions. Next, it explains criteria that may warrant conduct of in vivo P-gp-mediated drug interaction studies based on in vitro assessment. In addition, it includes a review case that describes the evaluation of data suggesting a P-gp-based induction interaction.
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Cites
Wu, C.-Y., & Benet, L. Z. (2005) · Pharmaceutical Research · doi:10.1007/s11095-004-9004-4 · Cited by 1,401
EVALUATION OF DRUG-DRUG INTERACTION IN THE HEPATOBILIARY AND RENAL TRANSPORT OF DRUGS
Shitara, Y., Sato, H., & Sugiyama, Y. (2005) · Annual Review of Pharmacology and Toxicology · doi:10.1146/annurev.pharmtox.44.101802.121444 · Cited by 336
Cited by
Membrane transporters in drug development
The International Transporter Consortium, Giacomini, K. M., Huang, S.-M., Tweedie, D. J., Benet, L. Z., Brouwer, K. L. R., Chu, X., Dahlin, A., Evers, R., Fischer, V., et al. (2010) · Nature Reviews Drug Discovery · doi:10.1038/nrd3028 · Cited by 3,340
Self-citationGodoy, P., Hewitt, N. J., Albrecht, U., Andersen, M. E., Ansari, N., Bhattacharya, S., Bode, J. G., Bolleyn, J., Borner, C., Böttger, J., et al. (2013) · Archives of Toxicology · doi:10.1007/s00204-013-1078-5 · Cited by 1,280
Population-Based Mechanistic Prediction of Oral Drug Absorption
Jamei, M., Turner, D., Yang, J., Neuhoff, S., Polak, S., Rostami-Hodjegan, A., & Tucker, G. (2009) · The AAPS Journal · doi:10.1208/s12248-009-9099-y · Cited by 452
Shitara, Y., Maeda, K., Ikejiri, K., Yoshida, K., Horie, T., & Sugiyama, Y. (2013) · Biopharmaceutics & Drug Disposition · doi:10.1002/bdd.1823 · Cited by 418
Jamei, M., Dickinson, G. L., & Rostami-Hodjegan, A. (2009) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.24.53 · Cited by 368
Metadata
- Authors
- Zhang, L., Zhang, Y. (. )., Strong, J. M., Reynolds, K. S., & Huang, S.-M.
- Venue
- Xenobiotica
- Publisher
- Informa UK Limited
- Published
- 2008-08
- Volume
- 38
- Issue
- 7-8
- Pages
- 709-724
- ISSN
- 0049-8254 (ISSN-L)
- 1366-5928
- OpenAlex
- W2087063957
- Cited by
- 188
- References
- 2
- FWCI
- 11.40
- Type
- journal article
- Language
- en
- Open access
- closed
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- Zhang, L., Zhang, Y. (. )., Strong, J. M., Reynolds, K. S., & Huang, S.-M. (2008). A regulatory viewpoint on transporter-based drug interactions. Xenobiotica. https://doi.org/10.1080/00498250802017715
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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