Services
Clinical Development
Clinical Pharmacology Plan (CPP) Development: Designing a comprehensive Clinical Pharmacology Plan that outlines the studies required to support drug development, including first-in-human (FIH) trials and special population studies.
Clinical Trial Design and Protocol Development: Assisting in the design and development of clinical trial protocols, including Phase I-IV studies, with a focus on pharmacology endpoints.
Dose Optimization and Regimen Design: Recommending optimal dosing strategies for different patient populations, including special populations such as pediatrics and geriatrics.
Pharmacokinetic and Pharmacodynamic (PK/PD) Modeling and Analysis: Designing and interpreting PK/PD studies to understand drug absorption, distribution, metabolism, and excretion (ADME).
Population Pharmacokinetics (PopPK) Analysis: Conducting population PK analysis to identify variability in drug response and optimize dosing in diverse patient populations.
Physiologically-Based Pharmacokinetic (PBPK) Modeling: Developing and utilizing PBPK models to predict drug behavior in different scenarios, such as organ impairment or specific demographic groups.
Scientific and Technical Writing: Preparing comprehensive reports, scientific publications, and regulatory documents that effectively communicate clinical pharmacology data and findings.
Preclinical and Translational Development
Preclinical Development Strategy: Designing and optimizing preclinical study plans to ensure robust pharmacokinetic, pharmacodynamic, and toxicological data support clinical entry decisions.
Dose Prediction and First-in-Human (FIH) Dose Selection: Utilizing preclinical PK/PD data and modeling to predict human doses, ensuring safe and effective first-in-human (FIH) studies.
Regulatory Submissions for IND/CTA: Preparing and reviewing the pharmacology and toxicology sections of regulatory submissions (e.g., IND, CTA) and ensuring compliance with regulatory guidelines.
Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling and Simulation: Applying PK/PD modeling to translate preclinical data into human scenarios, supporting dose selection and regimen optimization in early clinical development.
Translational Science Strategy: Developing a translational strategy that bridges preclinical findings to early clinical studies, including the identification of biomarkers and surrogate endpoints.
Strategic and Regulatory Advice
Regulatory Strategy Development: Crafting a tailored clinical pharmacology strategy that aligns with regulatory requirements and accelerates drug approval timelines.
Regulatory Submissions and Interactions: Guiding the preparation of key regulatory submissions (e.g., IND, NDA, BLA) and facilitating interactions with agencies like the FDA, EMA, and other global regulatory bodies.
Pediatric and Orphan Drug Development Strategies: Advising on strategies for pediatric drug development and orphan drug designations, including compliance with regulatory guidelines.
Labeling and Prescribing Information Support: Assisting in the development of clinically relevant labeling that reflects the drug’s pharmacokinetic and pharmacodynamic profile, including dose adjustments for specific populations.
Regulatory Risk Assessment and Mitigation: Identifying potential regulatory risks in clinical pharmacology and developing strategies to mitigate them.
Regulatory Guidance Interpretation: Providing expert interpretation of regulatory guidance documents and advising on their application in clinical pharmacology studies.
F.A.Q.
PK/PD modeling and simulation are powerful tools that help predict how a drug behaves in different populations, including healthy volunteers and patients. These models use preclinical and early clinical data to simulate various dosing scenarios, optimize dose selection, and minimize risks, thus supporting more efficient and effective drug development.
Selecting the FIH dose involves careful consideration of preclinical pharmacokinetic, pharmacodynamic, and toxicological data. Factors include the drug’s mechanism of action, therapeutic window, safety margins observed in animal models, and any species-specific differences in drug metabolism. The goal is to choose a dose that is both safe and likely to be effective, ensuring patient safety while maximizing the potential for clinical success.
During preclinical development, potential DDIs are assessed by evaluating a drug candidate’s ability to inhibit or induce key metabolic enzymes, such as cytochrome P450 enzymes, and transporters like P-glycoprotein. In vitro studies using human liver microsomes, hepatocytes, or recombinant enzymes can help identify these interactions. Results from these studies guide further in vivo studies and inform clinical development strategies to manage potential DDIs. PBPK modeling can be a great tool to understand the magnitude of DDI and help select Clinical Studies
Bioanalytical method development and validation are critical to ensuring accurate and reliable quantification of drugs and their metabolites in biological samples (e.g., plasma, urine, tissues). Robust bioanalytical methods enable precise measurement of drug concentrations, which is essential for interpreting pharmacokinetic data, understanding drug metabolism pathways, and making informed decisions during drug development. It is required for IND/CTA submissions as well as NDA/BLA submissions
Quantitative clinical pharmacologists contribute to regulatory submissions by providing modeling and simulation data that support critical decisions in drug development, such as dose selection, exposure-response relationships, and risk assessment. These analyses help justify dosing recommendations, demonstrate efficacy and safety across different populations, and address regulatory questions or concerns, thereby facilitating the approval process by regulatory agencies like the FDA and EMA.