Apply FDA/ EMA/ ICH M9 - aligned timepoint selection before calculating f2 - without reopening multiple guidance documents or excel spreadsheets each time.
How Pocket f2 Select works
Regulatory guidance defines criteria.
Execution still depends on interpretation.
The f2 formula is the same.
The decision often is not.
Across analysts and projects, variation can still happen in:
The issue is not competence.
It is variability in execution before calculation.
In f2 evaluation, the formula is only part of the story.
If the timepoints are selected differently:
Pocket f2 Select applies the timepoint-selection logic automatically before f2 is calculated.
Pocket f2 Select is built for the moment that the dissolution profiles similarity question comes up.
Not later, when you're back at your desk with excel spreadsheets open.
Now picture this:
You're in that meeting
The dissolution data is in front of of you
Someone asks. "Are these batches similar?"
Instead of saying, "I need to recheck the guidance and comeback,"
You simply pull out your phone and open Pocket f2 Select
You enter the timepoints, mean values, and % RSD
And within moments, you have:
Pocket f2 Select is designed for fast, structured execution in real review and decision moments using widely referenced regulatory approaches.
Pocket f2 Select is released under a controlled paid beta to evaluate real-world usage and refine execution critiera outputs.
Cohort is intentionally limited.
For those who want to evaluate Pocket f2 Select on a real dissolution profile before committing to broader use.
Best for: First-time evaluation on real data
Most relevant for regular use
Designed for professionals who want repeated access to guidance aligned similarity evaluation in real workflows.
Best for: Regular individual use
For small teams who want to onboard together at a lower per-user early-access price.
Best for: Small groups evaluating access together
Prior to launch, the guidance-aligned timepoint selection logic was deployed in two structured Google Sheet trials with dissolution and CMC professionals.
The objective was not adoption - but executive validation.
Participants applied the tool to real comparative profiles across development and submission contexts.
Feedback confirmed:
The underlying regulatory logic remained unchanged from field trial to Pocket release.
What evolved was the delivery layer - the transition from Google sheet to mobile delivery was driven by real-world usage patterns, enabling application at the point of execution.
Pocket f2 Select is currently available under a limited paid beta to further evaluate real-world application at scale.
A: Pocket f2 Select is a controlled beta decision-support module. it is not positioned as a validated enterprise GxP system. Final decisions and regulatory responsibility remain with the organization.
A: No. It standardizes execution criteria for comparative dissolution evaluation. Scientific review remains essential.
A: The module applies comparative dissolution expectations relfected across FDA, EMA and ICH M9 guidance for immediate-release solid oral dosage forms. Criteria are encoded as structured execution rules to support consistent application.
A: The execution logic is version-controlled. Updates are released as expectations evolve, and the current logic version is visible within the module.
A: Pocket f2 Select currently supports immediate-release oral dosage forms. Other dosage forms may be considered as separate modules in the future.
A: Outputs are structured to support internal review discussions and comparative narrative preparation. Final submission positioning remains the responsibility of the organization.
A: Yes. Pocket f2 Select is accessible on both mobile and desktop environments. It is designed for use at the point of execution - whether in the lab, during review discussions, or while preparing a comparative narrative.
A: Access for
during the controlled beta period, including any updates released within that window.
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