We operate in the areas of model-informed drug development, pharmacometrics, clinical pharmacology, statistics, physiologically based pharmacokinetics, quantitative systems pharmacology, biopharmaceutics and regulatory strategy.
Questions that we typically address include: “What concentration levels are necessary in humans?”, “What dose level is associated with the best overall efficacy-safety profile?”, “How can the experimental study design be improved to increase the probability of its success?”…

Pharmetheus offers consulting services focused on the application of quantitative approaches to support drug research, development and life-cycle decisions.

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Modeling and simulation support for regulatory approvals of caplacizumab

December 6, 2021

Modeling and simulation has played an important role in supporting regulatory approvals of caplacizumab for treatment of acquired thrombotic thrombocytopenic purpura (aTTP). For example, in 2018 the EMA agreed that clinical studies of caplacizumab in the pediatric population are not feasible. Alternatively, a modeling and simulation approach was applied to identify an appropriate dosing strategy in children. As a result, in Europe, a pediatric label extension was approved in 2020.


The modeling and simulation study at the basis of this label extension is described in this recent publication.

Services

Our services include quantitative analyses by scientists with extensive therapeutic area experience industry, academic and regularly settings.

Our team

Pharmetheus consultants and advisors present a unique collection of experiences and combination of skill sets.
QC and Medical Writer
Senior Consultant
Service Desk Manager
Board Member
Chief Financial Officer
Principal Consultant & Chief Statistician
Associate Consultant
Principal Consultant
Senior Consultant
Consultant
Associate Consultant
Principal Consultant & Team Leader
Analyst Systems Developer
QC and Medical Writer
Associate Consultant
Data Programmer
Board Member
Associate Data Programmer
Advisor
Principal Consultant, Team Leader & Board Member
Data Programmer & Team Leader
Associate Consultant
Associate Consultant
Contracts Manager
Human Resources Manager
Senior Consultant, Quality Assurance Officer & Team Leader
System Administrator
Consultant
Consultant
Consultant
Senior Consultant
Principal Consultant
Senior Consultant
Project Coordinator
Advisor & Chair of the Board
Analyst System Administrator
Associate Consultant & System Developer
Administrative Assistant
Principal Consultant & Team Leader
Consultant
Chief Executive Officer
Analyst QC and Medical Writer

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How we work

Our way of working, with traceability and accountability from data programming to report delivery, is well adapted to, and highly compatible with, current regulatory requirements.