ScienceStrategic consulting and incisive data analysis across all phases of drug development

Featured services

Clinical pharmacologyExpert guidance on regulatory and development decision-making PharmacometricsModeling and simulation behind your clinical strategy Noncompartmental analysisReproducible, submission-ready descriptive analyses

By stage

PreclinicalIND-enabling Phase 1/2First-in-human Pivotal trialConfirmatory NDA/BLAMarket authorization

Tools

ER thresholdsCalculator Multi-compartment PKCalculator Case studiesFrom the blog

See all services

TechnologyGxP-compliant software for pharma and life sciences; purpose-built and battle-tested

Services Application and dashboard developmentCustom apps and dashboards for complex data Posit Team infrastructure supportSecure, scalable Posit deployments for your team Training and processConsultation and training for custom-built workflows

Products A2-Ai CloudOur secure cloud-computing environment for life sciences AlexandriaOur centralized, versioned publishing platform PRISMOur curated and stable R-package governance solution

Open source ReportifyrOur Word plug-in that enables traceable reporting rvOur R package manager built for speed and reproducibility dvsData version control for large and sensitive datasets

Products Open source

About us Careers

Science

Explore science

Featured services

Clinical pharmacology Pharmacometrics Noncompartmental analysis

By stage

Preclinical Phase 1/2 Pivotal trial NDA/BLA

Tools

ER thresholds Multi-compartment PK Case studies

See all services

Technology

Explore technology

Services Application and dashboard development Posit Team infrastructure support Training and process

Products A2-Ai Cloud Alexandria PRISM

Open source Reportifyr rv dvs

Software

Products Open source

Services Leadership Blog

Company

About us Careers

Tag

fda guidance

Categories

blog case studies news products research spotlights services tooling updates

Tags

2025 adam adme aging ai allometric scaling animal models animal testing annual approval process between-subject variability body weight

RSS See all filters

New FDA Guidance on QTc Labeling: What Drug Developers Need to Know

Meg Gonsalves · December 8, 2025

Science

C-QT modeling for TQT study waivers
Clinical pharmacology
Clinical trial design
Exposure-response modeling of efficacy and safety
IND support
Mechanistic modeling (PBPK and QSP)
MIDD Paired Meeting Program
NDA/BLA support
Noncompartmental analysis
Pharmacokinetic and pharmacodynamic modeling and simulation
Pharmacometrics
Project Optimus
Translational modeling for FIH dose selection

Technology

Application and dashboard development
Posit Team infrastructure support
SAS migration support
Support services
Technology services
Training and enablement
Validation services

Software

Products

A2-Ai Cloud
Alexandria
PRISM
Sage AI

Open source

reportifyr
rv
dvs

Company

About us
Leadership
Careers
Contact

Resources

Blog
Case studies
ER thresholds
Multi-compartment PK

Topics

Pharmacometrics
Clinical pharmacology
Infrastructure
R
Regulatory initiatives
Shiny
Noncompartmental analysis
Posit

2723 S. State Street, Suite 310, Ann Arbor, MI 48104

© 2026 A2-Ai LLC. All rights reserved. Attributions