[HTML][HTML] Evaluation of rosuvastatin-induced QT prolongation risk using real-world data, in vitro cardiomyocyte studies, and mortality assessment

Y Koo, SA Hyun, BJ Choi, Y Kim, TY Kim, HS Lim… - Scientific Reports, 2023 - nature.com
… also affected the sodium and calcium channel activities of … by the Food and Drug
Administration in 2003, is used to treat … , rosuvastatin should be used with active monitoring for QT …

Trends in FDA Transporter‐Based Post‐Marketing Requirements and Commitments Over the Last Decade

IR Younis, P Manchandani… - Clinical Pharmacology …, 2022 - Wiley Online Library
… and sponsors agree should be conducted post-approval with … or labeling suggest monitoring
and dose adjustment as … P-gp, 2 PMRs specified rosuvastatin as a probe substrate for …

[HTML][HTML] Pharmacokinetic interactions and tolerability of rosuvastatin and ezetimibe: a randomized, phase 1, crossover study in healthy Chinese participants

L Wang, Y Luan, C Jia, X Xie, Z Zhang, X Xie… - European Journal of …, 2023 - Springer
rosuvastatin has better efficacy in improving lipid profile than other molecules of the same
class … The US Food and Drug Administration recommends that rosuvastatin therapy in Asian …

Understanding the impact of ABCG2 Polymorphisms on Drug Pharmacokinetics: Focus on rosuvastatin and allopurinol

A Kasten, I Cascorbi - Expert Opinion on Drug Metabolism & …, 2024 - Taylor & Francis
… This review focusses on the impact of genetic variants on the … The United States Food and
Drug Administration (FDA) … Paradoxically, the low activity ABCG2 variant was found to be …

Independent risk factors for simvastatin-related myopathy and relevance to different types of muscle symptom

JC Hopewell, A Offer, R Haynes, L Bowman… - European heart …, 2020 - academic.oup.com
… The findings of this study have implications both to help guide safety monitoring with statin
… blood levels for rosuvastatin, atorvastatin, and simvastatin acid, suggesting a class effect. …

Lessons learnt from the preclinical discovery and development of ensitrelvir as a COVID-19 therapeutic option

S Ferraro, I Convertino, E Cappello… - Expert Opinion on …, 2024 - Taylor & Francis
… Therefore, dose adjustment or monitoring may be … The FDA approved SARS-CoV-2 antivirals
available on the market … between ensitrelvir and midazolam, rosuvastatin, and digoxin has …

Ribociclib may potentiate rosuvastatin effect in causing late onset rhabdomyolysis

SW Teo, T Hayes, J Gome - BMJ Case Reports CP, 2023 - casereports.bmj.com
… while on a combination of ribociclib and rosuvastatin therapy. She had been taking both …
This is the first case in which the combination of ribociclib and rosuvastatin has been shown …

New drug formulary management and utilization: evidence in sex, race, and ethnicity: 2019-2020

CA Keeys, BW Harding, GE Migneco… - Annals of …, 2022 - journals.sagepub.com
… and post-approval study requirements for recent FDA-approvedreviews (DURs) and
adverse drug reaction monitoring. … , which resulted in rosuvastatin product labeling changes for …

Impact of real-world data on market authorization, reimbursement decision & price negotiation

AA Pulini, GM Caetano, H Clautiaux… - … Innovation & Regulatory …, 2021 - Springer
… Historically, the FDA has focused its use of RWD on safety … that is already approved or to
support or satisfy post-approval study … an opportunity for machine learning/artificial intelligent …

[HTML][HTML] A new era for oral peptides: SNAC and the development of oral semaglutide for the treatment of type 2 diabetes

VR Aroda, L Blonde, RE Pratley - Reviews in Endocrine and Metabolic …, 2022 - Springer
… US Food and Drug Administration (FDA)-approved indication … profile consistent with that of
the GLP-1RA class [65]. Based on … that require clinical monitoring, such as levothyroxine [24, …