Modeling and Experimental Studies of Obeticholic Acid Exposure and the Impact of Cirrhosis Stage Publication Modeling and Experimental Studies of Obeticholic Acid Exposure and the Impact of Cirrhosis Stage CertaraDecember 1, 2016
A Randomized Dose Escalation Study of Intravenous Baclofen in Healthy Volunteers: Clinical Tolerance and Pharmacokinetics Publication A Randomized Dose Escalation Study of Intravenous Baclofen in Healthy Volunteers: Clinical Tolerance and Pharmacokinetics CertaraNovember 17, 2016
Impact of Target-mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Publication Impact of Target-mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) CertaraNovember 15, 2016
Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug Blog Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a…CertaraOctober 21, 2016
Profiling the Relationship Between Tumor-associated Macrophages and Pharmacokinetics of Liposomal Agents in Preclinical Murine Models Publication Profiling the Relationship Between Tumor-associated Macrophages and Pharmacokinetics of Liposomal Agents in Preclinical Murine Models CertaraOctober 5, 2016
Gulp1 is Associated with the Pharmacokinetics of PEGylated Liposomal Doxorubicin (PLD) in Inbred Mouse Strains Publication Gulp1 is Associated with the Pharmacokinetics of PEGylated Liposomal Doxorubicin (PLD) in Inbred Mouse Strains CertaraOctober 1, 2016
Rare Disease and Orphan Drug Development Brochure Rare Disease and Orphan Drug Development There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these…CertaraAugust 3, 2016
Population Pharmacokinetics of Bevacizumab in Cancer Patients with External Validation Publication Population Pharmacokinetics of Bevacizumab in Cancer Patients with External Validation CertaraAugust 1, 2016
Model-based Meta-analysis: An Innovative Methodology Comes of Age White Paper Model-based Meta-analysis: An Innovative Methodology Comes of Age MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions.…CertaraJuly 14, 2016
Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development Publication Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development CertaraJuly 1, 2016