Designing and preparing for first-in-human (FIH) studies is a critical stage in early drug development. The likelihood of success requires meticulous preparation by various teams such as clinical pharmacology, drug metabolism/pharmacokinetics (DMPK), translational medicine, and study execution. Certara offers consulting and software solutions to support all facets of FIH study preparation, from study design planning and execution, to modeling and simulation for FIH dose projections.
First-in-Human (FIH) Dose Predictions
Industry-leading services and technological solutions to predict FIH dosing
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Model-informed confidence in first-in-human dose predictions
Expert study design, planning and execution
- Broad indication and novel modality expertise to determine best-fit mathematical strategy for your drug development program
- Comprehensive operational support ensuring compliance and readiness
- Integrated team of global scientists provide tailored solutions, evidence-based recommendations, and cutting-edge tools to optimize dose prediction
Accurate FIH dose projections
- Comprehensive expertise in dose prediction strategy
- Full range of modeling solutions and guidance, including mechanistic PBPK and QSP and empirical PK/PD to generate evidence for your dose
- Experienced team that understands the nuances required to support confidence in your dose projection
Rigorous regulatory advice
- Unparalleled expertise preparing regulatory communications, including IND/CTA submissions
- Assemble your body of evidence to answer and anticipate regulatory questions
- Minimize the number of queries on filings by answering the right questions
Certara's first-in-human solutions
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Certara sets the benchmark for FIH dose predictions with our unparalleled combination of industry-leading technology, expert consulting, and proven results. Our innovative solutions empower clients to make more informed decisions, minimize risks, and accelerate drug development timelines.
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