Publication

Population Pharmacokinetics of Oral-Based Administration of Cannabidiol in Healthy Adults: Implications for Drug Development

See how uncovered large inter‑individual variability in CBD pharmacokinetics, showing 3.6‑fold exposure differences and long…

CertaraApril 19, 2022

On-Demand Webinar

Smarter Clinical Document Automation for Transparency and Disclosure Requirements

Transparency and disclosure efforts are an integral part of medical writing for submissions. Sponsors receive…

CertaraApril 14, 2022

Case Study

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…

CertaraApril 11, 2022

Publication

Pharmacokinetics and Safety of Ferric Pyrophosphate Citrate in Chinese Subjects with and without Hemodialysis-Dependent Stage 5 Chronic Kidney Disease

Discover how evaluated ferric pyrophosphate citrate pharmacokinetics and safety in healthy and hemodialysis‑dependent CKD patients…

CertaraApril 5, 2022

Publication

Population Pharmacokinetic (Pop-PK) Analysis of Torsemide in Healthy Korean Males Considering CYP2C9 and OATP1B1 Genetic Polymorphisms

Explore how CYP2C9 and OATP1B1 genetic effects on torsemide PK in healthy Korean males, supporting…

CertaraApril 1, 2022

Blog

5 reasons why you should use Phoenix WinNonlin for PK/PD analyses

Pharmaceutical companies around the globe face the challenge of increasingly longer drug development cycles and…

CertaraMarch 25, 2022

Publication

Co-Administration with Voriconazole Doubles the Exposure of Ruxolitinib in Patients with Hematological Malignancies

Find out how voriconazole more than doubles ruxolitinib exposure, supporting dose adjustment guidance for hematologic…

CertaraMarch 25, 2022

Fact Sheet

SEND Explorer – Product Family

Discover how SEND Explorer transforms nonclinical data analysis.

CertaraMarch 23, 2022

On-Demand Webinar

eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus

Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated…

CertaraMarch 22, 2022

Video

The Value of BaseCase

CertaraMarch 21, 2022

Population Pharmacokinetics of Oral-Based Administration of Cannabidiol in Healthy Adults: Implications for Drug Development

Smarter Clinical Document Automation for Transparency and Disclosure Requirements

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

Pharmacokinetics and Safety of Ferric Pyrophosphate Citrate in Chinese Subjects with and without Hemodialysis-Dependent Stage 5 Chronic Kidney Disease

Population Pharmacokinetic (Pop-PK) Analysis of Torsemide in Healthy Korean Males Considering CYP2C9 and OATP1B1 Genetic Polymorphisms

5 reasons why you should use Phoenix WinNonlin for PK/PD analyses

Co-Administration with Voriconazole Doubles the Exposure of Ruxolitinib in Patients with Hematological Malignancies

SEND Explorer – Product Family

eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus

The Value of BaseCase

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