Evaluation of long-term stability data and shelf-life estimation in compliance with ICH Q1E, ICH Q1A (R2) and Q5C. Rational approach to establish release limits consistent with acceptance criteria and compliant with Q6A and Q6B.
Evaluation of long-term stability data and shelf-life estimation in compliance with ICH Q1E, ICH Q1A (R2) and Q5C. Rational approach to establish release limits consistent with acceptance criteria and compliant with Q6A and Q6B.
Precise protocol information and purpose of the study. Add the claimed shelf life to verify that your parameters meets it.
Precise protocol information and purpose of the study. Add the claimed shelf life to verify that your parameters meets it.
Play and replay analyses in the simplest way with the import assistant.
Load direclty an example dataset into the application and get quickly an overview of functionalities.
Play and replay analyses in the simplest way with the import assistant.
Load direclty an example dataset into the application and get quickly an overview of functionalities.
Visualize your parameters to validate data and assumptions before running the analysis.
Visualize your parameters to validate data and assumptions before running the analysis.
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