Dissolution Profile Comparison

1. What this module does

You enter the 12 individual results of each batch at each time point in each medium. The tool calculates the means and CVs, applies the rule that both batches at 85% or more in 15 minutes are similar, checks whether f2 can be used and calculates it over the right time points.

For a BCS biowaiver it checks the ICH M9 conditions for class I and class III substances.

What you get

• A Word or PDF report: Dissolution profile comparison, with a profile chart for each medium.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• Test and reference batches and the test conditions.
• Individual results (12 units) at each time point in each medium.
• For a biowaiver: the BCS class and the excipient comparison.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/dissolution-comparison.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the comparison

   Choose the purpose, enter the batches and the test conditions. For a BCS biowaiver, choose the class.

   

2. Enter the profiles

   One row per medium and time point, with the 12 results of each batch separated by ";".

3. Read the result

   The headline gives the conclusion: "Similar in all 3 media". The note gives f2 or the rapid-dissolution rule for each medium.

   

4. Resolve alerts and download

   f2 below 50 is critical. Fewer than 12 units, fewer than three points, CVs above the limits and missing biowaiver conditions are flagged. Then preview and download.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Comparison

2 · Profiles

One row per medium and time point, with the 12 individual results (% dissolved) of each batch separated by ";".

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• f2 over the points up to the first at which either batch reaches 85%.
• CV ≤ 20% at points up to 10 minutes and ≤ 10% after; 12 units; at least three points.
• ICH M9: class I ≥85% in 30 min, class III ≥85% in 15 min, pH 1.2, 4.5 and 6.8, excipients assessed.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Discussion and conclusion. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US follows SUPAC-IR Appendix B and the FDA dissolution guidance. EU follows Appendix I of the EMA bioequivalence guideline and its Q&A on f2. Both follow ICH M9 for BCS biowaivers.

8. Working with other modules

• Development data go in the Development Studio.
• For the change itself, see the Post-approval Change Classifier module.

9. Common pitfalls

• Including several points after 85% dissolution, which inflates f2.
• Using f2 when the CV is too high.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Ask for a biowaiver for a class II substance

   Set the purpose to BCS-based biowaiver and the class to Class II or IV.

   Expected resultA critical alert says class II or IV substances are not eligible.