Publication

Pharmacokinetic and Bioequivalent Study of Potassium Chloride Sustained-Release Tablet Under Different Dietary Conditions in Healthy Chinese Subjects

Learn how urinary potassium excretion comparable across formulations and diets; BE confirmed using Phoenix WinNonlin.

CertaraNovember 2, 2022

Case Study

Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy

Olanzapine is an effective antipsychotic medication used to treat schizophrenia, a disease that affects about…

CertaraOctober 31, 2022

Publication

Pharmacokinetics of L-Citrulline in Neonates at Risk of Developing Bronchopulmonary Dysplasia-Associated Pulmonary Hypertension.

Find out how short 16‑min half‑life; simulations support 37–52 mg/kg QID dosing using Phoenix WinNonlin.

CertaraOctober 31, 2022

Blog

Why you should select your drug formulation before starting clinical studies

Drug developers often rush through the discovery process to get into human testing. Most are…

CertaraOctober 28, 2022

Publication

Population Pharmacokinetic Analysis of Valsartan in Healthy Chinese Subjects

Explore how food affects absorption; liver enzymes and creatinine influence clearance in valsartan PopPK using…

CertaraOctober 26, 2022

Press Coverage

Accelerating Market Access with Data-Driven Payer Engagement

Using data visualizations to improve access to payers. With the switch to more digital environments,…

CertaraOctober 25, 2022

Pediatrician examining cute baby in clinic, closeup

On-Demand Webinar

Applications of PBPK modelling for regulatory submissions: case studies involving DDIs, transporters and special populations

Over the past two decades, there have been transformative changes in our approach to using…

CertaraOctober 20, 2022

Press Coverage

Simultaneous FDA & EMA Submissions for Drug Approvals

Is there a better way? The question always breeds critical thinking and often leads to…

CertaraOctober 19, 2022

On-Demand Webinar

RAPS sponsored webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 months

Join us on November 10th for this webcast being held in partnership with RAPS. The…

CertaraOctober 17, 2022

Blog

PBPK modeling & simulation of therapeutic oligonucleotides from bench to bedside

Next generation therapeutics Oligonucleotide drugs are unique among therapeutic modalities in that they don’t engage…

CertaraOctober 14, 2022

Pharmacokinetic and Bioequivalent Study of Potassium Chloride Sustained-Release Tablet Under Different Dietary Conditions in Healthy Chinese Subjects

Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy

Pharmacokinetics of L-Citrulline in Neonates at Risk of Developing Bronchopulmonary Dysplasia-Associated Pulmonary Hypertension.

Why you should select your drug formulation before starting clinical studies

Population Pharmacokinetic Analysis of Valsartan in Healthy Chinese Subjects

Accelerating Market Access with Data-Driven Payer Engagement

Applications of PBPK modelling for regulatory submissions: case studies involving DDIs, transporters and special populations

Simultaneous FDA & EMA Submissions for Drug Approvals

RAPS sponsored webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 months

PBPK modeling & simulation of therapeutic oligonucleotides from bench to bedside

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