On-Demand Webinar

Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges

Therapeutic proteins (TP) - and more specifically monoclonal antibodies - are part of the therapeutic…

CertaraDecember 5, 2022

Publication

Establishment of PK-PD model in anti-inflammatory active components in Inula cappa extract based on lipopolysaccharide-induced in vitro inflammation model

Discover how PK‑PD modelling shows anti‑inflammatory components reduce NO and TNF‑α in inflamed cells using…

CertaraDecember 1, 2022

Publication

Pharmacokinetics and pharmacodynamics of polymyxin B and proposed dosing regimens in elderly patients with multi-drug-resistant Gram-negative bacterial infections

See how fixed 50–75 mg dosing meets PK/PD targets; albumin has minor PK impact using…

CertaraNovember 11, 2022

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

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

Blog

3 takeaways from the FDA oligo guidance you need to know

In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance . This…

CertaraSeptember 23, 2022

Publication

Evaluating the efficacy of prototype antiseizure drugs using a preclinical pharmacokinetic approach

Discover how species differences in PK and metabolite ratios explain efficacy variation using Phoenix WinNonlin.

CertaraSeptember 11, 2022

Publication

Early change in the clearance of pembrolizumab reflects the survival and therapeutic response: A population pharmacokinetic analysis in real-world non-small cell lung cancer patients

See how early clearance drop predicts better response and survival; PopPK built using Phoenix NLME.

CertaraSeptember 6, 2022

Clinical Pharmacology

Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges

Establishment of PK-PD model in anti-inflammatory active components in Inula cappa extract based on lipopolysaccharide-induced in vitro inflammation model

Pharmacokinetics and pharmacodynamics of polymyxin B and proposed dosing regimens in elderly patients with multi-drug-resistant Gram-negative bacterial infections

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

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

3 takeaways from the FDA oligo guidance you need to know

Evaluating the efficacy of prototype antiseizure drugs using a preclinical pharmacokinetic approach

Early change in the clearance of pembrolizumab reflects the survival and therapeutic response: A population pharmacokinetic analysis in real-world non-small cell lung cancer patients

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