FreeThink Technologies, Inc. offer service "Accelerated Stability Assessment Program (ASAP) and Laboratory Services"
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Accelerated Stability Assessment Program (ASAP) and Laboratory Services
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- Study Conditions: Runs both GMP and non-GMP accelerated-stability chambers at ICH-aligned humidity/temperature profiles (e.g. 25°C/60% RH, 40°C/75% RH), supplemented by ASAP's proprietary elevated-stress isotherms that model degradation kinetics beyond standard ICH conditi
- Time Points: ASAPprime predictive modeling can estimate shelf-life from as little as 4 weeks of accelerated-stress data, while conventional real-time/accelerated protocols follow standard pull points (0, 1, 3, 6, 9, 12, 18, 24 months).
- Chamber Capacity: Multiple walk-in and reach-in environmental chambers across FreeThink's US laboratory network, sized to run concurrent GMP and non-GMP stability batches for pharmaceutical, nutraceutical, and consumer-product clients.
- Protocol Design: Custom stability protocols combine ASAP predictive modeling with traditional ICH Q1A(R2)-based long-term/accelerated/intermediate designs, including degradation-indicating analytical method development support.
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