Therapeutic protein drug interactions: a white paper from the international consortium for innovation and quality in pharmaceutical development
…, C Grimaldi, JNS Pereira, C Säll… - Clinical …, 2023 - Wiley Online Library
Typically, therapeutic proteins (TPs) have a low risk for eliciting meaningful drug interactions
(DIs). However, there are select instances where TP drug interactions (TP‐DIs) of clinical …
(DIs). However, there are select instances where TP drug interactions (TP‐DIs) of clinical …
Reduced Physiologically-Based Pharmacokinetic Model of Repaglinide: Impact of OATP1B1 and CYP2C8 Genotype and Source of In Vitro Data on the Prediction of …
M Gertz, N Tsamandouras, C Säll, JB Houston… - Pharmaceutical …, 2014 - Springer
Purpose To investigate the effect of OATP1B1 genotype as a covariate on repaglinide
pharmacokinetics and drug-drug interaction (DDIs) risk using a reduced physiologically-based …
pharmacokinetics and drug-drug interaction (DDIs) risk using a reduced physiologically-based …
A comprehensive assessment of repaglinide metabolic pathways: impact of choice of in vitro system and relative enzyme contribution to in vitro clearance
C Säll, JB Houston, A Galetin - Drug Metabolism and Disposition, 2012 - ASPET
Repaglinide is presently recommended by the US Food and Drug Administration as a clinical
CYP2C8 probe, yet current in vitro and clinical data are inconsistent concerning the role of …
CYP2C8 probe, yet current in vitro and clinical data are inconsistent concerning the role of …
In Vitro CYP450 Enzyme Downregulation by GLP-1/Glucagon Coagonist Does Not Translate to Observed Drug-Drug Interactions in the Clinic
C Säll, L Alifrangis, K Dahl, MH Friedrichsen… - Drug Metabolism and …, 2022 - ASPET
NN1177 is a glucagon/glucagon-like peptide 1 receptor coagonist investigated for chronic
weight management and treatment of nonalcoholic steatohepatitis. Here, we show …
weight management and treatment of nonalcoholic steatohepatitis. Here, we show …
Evaluation of 309 molecules as inducers of CYP3A4, CYP2B6, CYP1A2, OATP1B1, OCT1, MDR1, MRP2, MRP3 and BCRP in cryopreserved human hepatocytes in …
L Badolo, B Jensen, C Säll, U Norinder, P Kallunki… - Xenobiotica, 2015 - Taylor & Francis
Regulation of hepatic metabolism or transport may lead to increase in drug clearance and
compromise efficacy or safety. In this study, cryopreserved human hepatocytes were used to …
compromise efficacy or safety. In this study, cryopreserved human hepatocytes were used to …
Industry perspective on therapeutic peptide drug–drug interaction assessments during drug development: a European Federation of Pharmaceutical Industries and …
C Säll, U Argikar, K Fonseca… - Clinical …, 2023 - Wiley Online Library
… The WG consists of 10 company representatives and is led by Carolina Säll from Novo
Nordisk. Seven companies were EFPIA members (AstraZeneca, Janssen, Novartis, Novo Nordisk…
Nordisk. Seven companies were EFPIA members (AstraZeneca, Janssen, Novartis, Novo Nordisk…
Progress curve mechanistic modeling approach for assessing time-dependent inhibition of CYP3A4
HJ Burt, H Pertinez, C Säll, C Collins, R Hyland… - Drug Metabolism and …, 2012 - ASPET
A progress curve method for assessing time-dependent inhibition of CYP3A4 is based on
simultaneous quantification of probe substrate metabolite and inhibitor concentrations during …
simultaneous quantification of probe substrate metabolite and inhibitor concentrations during …
Evaluating drug-drug interaction risk associated with peptide analogues using advanced in vitro systems
Drug-drug interaction (DDI) assessment of therapeutic peptides is an evolving area. The
industry generally follows DDI guidelines for small molecules, but the translation of data …
industry generally follows DDI guidelines for small molecules, but the translation of data …
In vitro drug-drug interactions of decitabine and tetrahydrouridine involving drug transporters and drug metabolising enzymes
C Säll, C Fogt Hjorth - Xenobiotica, 2022 - Taylor & Francis
NDec is a novel, oral, fixed-dose formulation of decitabine and tetrahydrouridine that is currently
being developed for the treatment of patients with sickle cell disease. Here, we examine …
being developed for the treatment of patients with sickle cell disease. Here, we examine …
[HTML][HTML] In vitro interaction of tetrahydrouridine with key human nucleoside transporters
C Säll, G Koncsos, A Klukovits - Journal of Pharmaceutical Sciences, 2023 - Elsevier
NDec is a novel combination of oral decitabine and tetrahydrouridine that is currently under
clinical development for the treatment of sickle cell disease (SCD). Here, we investigate the …
clinical development for the treatment of sickle cell disease (SCD). Here, we investigate the …