XP Pharma Consulting works with you to translate preclinical DMPK, toxicology and pharmacology data to clinical study design for IND opening study. We offer following services:
Noncompartmental PK Analysis (NCA)
NCA analysis with validated software tools
NCA analysis results (tables, listings, and figures)
PK-dose proportionality
NCA analysis results interpretation
Submission ready reports
PK/PD Modeling and Simulation
Nonclinical PK/PD modeling
Allometric scaling
Population PK modeling across species
Dose selection and justification
Study design simulation
Human exposure prediction
Human PK/PD simulation
Submission ready reports authoring
Clinical Pharmacology Strategy and Writing
Gap analyses and due diligence (asset evaluation)
Clinical pharmacology plan
Clinical study design
IND study protocol authoring (in full or in part) and reviews
Regulation document preparation (PK/PD)
Clinical development plans (in full or in part) and reviews
Responses to regulatory questions (in full or in part) and reviews
