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Prediction of Drug-drug Interactions Arising from Mechanism-based Inactivation: Key Input Parameters and Impact on Risk Assessment Blog Post

As the prevalence of polypharmacy increases with our aging population, the propensity for adverse drug-drug interactions arising from the altered metabolism of co-administered medicines remains an important consideration for drug…

什么是 PK/PD 分析中的滞后现象？ Blog Post

I apologize to all my readers for such a long lapse between posts. After a very busy summer and fall, I am back to posting regularly to my blog about…

Safety and Population Pharmacokinetic Analysis of Intravenous Acetaminophen in Neonates, Infants, Children, and Adolescents with Pain or Fever Blog Post

The administration of acetaminophen via the oral and rectal routes may be contraindicated in specific clinical settings. Intravenous administration provides an alternative route for fever reduction and analgesia. This phase…

Risk Assessment of Accidental Nortriptyline Poisoning: The Importance of Cytochrome P450 for Nortriptyline Elimination Investigated Using a Population-based Pharmacokinetic Simulator Blog Post

It is not possible to make a prospective clinical study that reveals the importance of the nortriptyline metabolising cytochrome P450 (CYP) isoforms (CYP1A2, CYP2C19, CYP2D6, and CYP3A4) in relation to…

Evaluation of Combined Bevacizumab and Intraperitoneal Carboplatin or Paclitaxel Therapy in a Mouse Model of Ovarian Cancer Blog Post

The purpose of this was to evaluate the pharmacokinetics of bevacizumab following IP and IV administration, and to investigate combined bevacizumab therapy (IP or IV) with IP paclitaxel or carboplatin…

Pharmacokinetics of SN2310, an Injectable Emulsion that Incorporates a New Derivative of SN-38 in Patients with Advanced Solid Tumors Blog Post

SN2310 is an injectable emulsion composed of vitamin E, a succinate derivative, as well as 7-ethyl-10-hydroxycamptothecin (SN-38), the active metabolite of irinotecan. Single intravenous doses of 15, 20, 25, and…

Are There Differences in the Catalytic Activity per Unit Enzyme of Recombinantly Expressed and Human Liver Microsomal Cytochrome P4502C9? A Systematic Investigation into Inter-system Extrapolation Factors Blog Post

The ‘relative activity factor’ (RAF) compares the activity per unit of microsomal protein in recombinantly expressed cytochrome P450 enzymes (rhCYP) and human liver without separating the potential sources of variation…

Effects of the Moderate CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fesoterodine in Healthy Subjects Blog Post

Available data suggest that fesoterodine dosage should not exceed 4 mg once daily when taken concomitantly with potent CYP3A4 inhibitors, such as ketoconazole. Currently, no information is available on whether…

In Vitro-In Vivo Extrapolation of CYP2C8-catalyzed Paclitaxel 6a-hydroxylation: Effects of Albumin on In Vitro Kinetic Parameters and Assessment of Interindividual Variability in Predicted Clearance Blog Post

This study aimed to characterize the effects of bovine serum albumin (BSA) on the kinetics of CYP2C8-catalyzed paclitaxel 6α-hydroxylation in vitro; determine whether the addition of BSA to incubations improves…

Ammonia Control in Children with Urea Cycle Disorders (UCDs); Phase 2 Comparison of Sodium Phenylbutyrate and Glycerol Phenylbutyrate Blog Post

Twenty four hour ammonia profiles and correlates of drug effect were examined in a phase 2 comparison of sodium phenylbutyrate (NaPBA) and glycerol phenylbutyrate (GPB or HPN-100), an investigational drug…

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