Clinical Pharmacology and Pharmacometrics Services
Uniphar Partners benefit from having a fully engaged, seasoned team on day 1, with expertise across all stages of development and product types, including NCEs, Repurposed NCEs, 505(b)(2)s, Biosimilars/Biobetters, Companion Diagnostics, and Combination Products.
Value
Accelerate development
Avoid missteps
Address Phase 1 liability
De-risk asset
Improve asset value
Clinical Pharmacology Service Areas
Drug Development Capabilities
- In vitro screening studies
- Phase 1 program development
- Phase 1 study design and execution (synopsis, protocol, oversight, and CSR)
Regulatory Affairs Support
- Pre-clinical and clinical trial application package development and meeting attendance
- EOP1/EOP2/Type A/Package and meeting attendance
Marketing Authorization Strategy and Submission
- Pre-clinical and clinical trial application package and meeting attendance
- Marketing application filing and regulatory liaison
- Product labeling development
- Advisory committee presentation
- iPSP support
Studies Supported
- Blood/protein binding
- In vitro screening
- SAD/MAD
- ADME
- DDI
- Renal/hepatic impairment
- Intrinsic and extrinsic factors (age, sex, ethnicity)
- Ethnobridge
- Linearity and dose proportionality
- Food Effect
- Pivotal Bioavailability/Bioequivalence
- High-precision QTc
Clinical Pharmacology Regulatory Expertise and Pharmacometrics Model-Informed Drug Development (MIDD)
- Leveraging nonclinical data for human predictive exposures for dose selection in FIH (First In Human)
- PK/PD modeling and simulation
- Population PK/PD
- Quantitative clinical drug development
- Noncompartmental analysis and reporting
- Exposure Response analysis
- Clinical Pharmacology protocols and study reports
- Dose-finding and justification
- Intrinsic/extrinsic factors meta-analysis
- iPSP support
Make informed clinical pharmacology and pharmacometrics decisions
Whether you need strategy, execution, or both, schedule a free 30‑minute consultation with Uniphar to discuss dose selection, Phase 1 study design/oversight, and regulatory strategy.
