Science
We know science.
Strategic consulting and incisive data analysis, from preclinical and first-in-human dose-selection, to the regulatory submission that puts your drug on the market. Our scientists are ready to integrate seamlessly into your development program.
Clinical pharmacology
Strategic decision making to guide your clinical pipeline, from IND to NDA submissions, with regulatory document support. We’ll help you identify gaps, mitigate risks, and defend your program to regulators.
Noncompartmental analysis
Traditional analyses and metrics that define the PK and PD characteristics of your drug and establish a ground truth to measure against. Generation of validated domains and interpretation for PK, ADA, PD, and any other domain you need insight into.
Pharmacometrics
Advanced mathematical and statistical analyses that quantify the outcomes and assumptions of your clinical strategy and align your program with modern regulatory standards for model-informed drug development.
Preclinical
The analyses and IND package that set up your first-in-human doses.
- Modeling that translates PK across species
- First-in-human dose estimation and exposure prediction
- Preclinical PBPK to predict drug-drug interactions, human PK, and guide formulation selection
- Clear and rational modeling analysis plans
- Study design support for your first-in-human study
- In-person support at pre-IND meetings and briefing book drafting
- Support drafting IND modules 2.6.4, 2.6.5, and 2.6.7
Phase 1/2
Analyses that fine-tune your dose, so your next cohort is designed and rationalized; lower your risk for rerunning at new doses.
- Noncompartmental analysis to understand dose-exposure relationships
- Modeling to characterize pharmacokinetics and pharmacodynamics
- Exposure-response analyses to evaluate safety and efficacy
- Simulations to support dose-finding and dose-optimization
- Shiny app development to explore your data
- In-person support at EOP1/2 meetings and briefing book drafting
- Support for MIDD Paired Meeting Program, with briefing book and regulatory document support
- Support drafting and reviewing clinical protocols and IBs
Pivotal trial
Design your study to account for uncertainty, then get the most out of your data. Clinical pharmacology, modeling/simulation, and writing support can prepare you for submission on time.
- Simulations to optimize clinical trial design
- Confirmatory exposure-response analyses and exploration of sub-populations of interest
- Renal, hepatic, and drug-drug interaction assessments
- Robust pediatric trial design
- Interim analyses and protocol amendments
NDA/BLA
The submission, the meeting after it, and analyses built for seamless reproduction in the hands of a reviewer.
- Submission-ready Population PK and exposure-response reports
- Clinical pharmacology summaries, dosing recommendations, and labeling support
- Strategic planning for information requests and advisory meetings
- In-person support at pre-NDA meetings and briefing book support
- Submission packages that are comprehensive and robust
- Authorship of Sections 2.6.4, 2.6.5, 2.7.1, and 2.7.2
- Co-authorship of 2.4, 2.6.6, 2.6.7, 2.7.3, and 2.7.4
Case study
Accelerating FDA Approval with MIDD: How A2-Ai Secured a New Dose Without a Phase 3 Trial
A case study in combining clinical pharmacology and pharmacometrics expertise to save time and money.
Read the case study
Utilities
Need a pharmacokinetic parameter or an effect threshold in a hurry? These browser-based tools provide quick answers.
Exposure-Response Thresholds
Calculate exposures needed to achieve common effect thresholds based on simple or sigmoidal maximum effect (Emax) models.
Multi-compartment PK Parameter Conversion Calculator
Convert clearance (CL) and volume (V) parameters for 2- and 3-compartment mammillary PK models to corresponding micro- and macro-rate constants. Derived half-lives and VSS are also output.
Updates
Case studies, model updates, and more
View all postsModelling notes, methods deep-dives and regulatory perspectives from the A2-Ai team.
