# Stage 12 — Regulatory Package Report
**Model:** ASMD/Xenpozyme QSP v2.0
**Stage 12 deliverable:** Eight-document regulatory submission bundle (DOCX + PDF + XLSX).

## 1. Documents produced

| ID | Document | DOCX | PDF | Pages |
|---|---|---|---|---|
| D0 | Parameter table (3 sheets, colour-coded) | `ASMD_Xenpozyme_QSP_v2_0_parameter_table.xlsx` | — | XLSX |
| D1 | Model equations | ✓ | ✓ | ~6 |
| D2 | References table (landscape, 39 refs Vancouver) | ✓ | ✓ | ~3 |
| D3 | Bayesian meta-analysis report | ✓ | ✓ | ~6 |
| D4 | Identifiability report | ✓ | ✓ | ~7 |
| D5 | Regulatory report (R1–R14, all 14 phases) | ✓ | ✓ | ~5 |
| D6 | Final manuscript (IMRAD, continuous prose) | ✓ | ✓ | ~8 |

All DOCX files use Calibri 11 pt, professional headings, running headers/footers, and embedded figures.
All PDF files are LibreOffice-rendered with embedded fonts and identical pagination.

## 2. Parameter table structure

Sheet 1 (Adult Parameters): 44 rows × 10 columns. Colour-coded by identifiability class:
- Green = Well-identifiable (RSE < 20 %)
- Amber = Moderately identifiable (20-50 %)
- Pink = Weakly identifiable (50-100 %)
- Grey = Non-identifiable (RSE ≥ 100 %)
- Light grey = Fixed/Initial (not fitted in v2.0)

Sheet 2 (Paediatric Parameters): same structure with population-specific values and override flag.

Sheet 3 (v1.3 → v2.0 Comparison): side-by-side comparison with percent change column for traceability.

Legend block at the bottom of Sheets 1 and 2 documents the colour coding.

## 3. Model equations document structure

12 sections covering scope and Context-of-Use, the 11 state variables, the equations for each of the six layers (PK, ADA, substrate, biomarkers, tissue burden, clinical observables), the paediatric height-Z block, parameter overrides, initial conditions, and the numerical solver. Important note on the linear-proportional reformulation in Stage 5 is included.

## 4. Reference table

39 Vancouver-style references covering:
- Clinical trials (R1, R2, R31)
- Mechanism (R3, R4, R7, R8, R32, R34)
- Biomarkers (R6, R32)
- Regulatory guidance (R9, R11, R12, R13, R14, R30, R35, R36)
- Methodology (R15-R20, R21-R25, R26-R28, R37-R39)

## 5. Regulatory report (R1–R14)

Fourteen-row table mapping each pipeline phase (R1–R14) to its method, key result, and credibility verdict. All ten ASME V&V40 credibility gates G1-G10 have a documented PASS or PASS-CONDITIONAL.

## 6. Manuscript

Standalone 8-page IMRAD continuous-prose article with Abstract, Introduction, Methods (architecture, calibration, V&V, sensitivity/identifiability/Bayesian), Results, Discussion, Conclusion, Funding, Conflicts of Interest, Data and Code Availability, and References. Targets CPT: Pharmacometrics & Systems Pharmacology.

## 7. Files
13 deliverable files in `/mnt/user-data/outputs/asmd_v2/stage12_regulatory/`:
- `ASMD_Xenpozyme_QSP_v2_0_parameter_table.xlsx`
- `ASMD_Xenpozyme_QSP_v2_0_model_equations.docx` + `.pdf`
- `ASMD_Xenpozyme_QSP_v2_0_references_table.docx` + `.pdf`
- `ASMD_Xenpozyme_QSP_v2_0_bayesian_meta_analysis_report.docx` + `.pdf`
- `ASMD_Xenpozyme_QSP_v2_0_identifiability_report.docx` + `.pdf`
- `ASMD_Xenpozyme_QSP_v2_0_regulatory_report.docx` + `.pdf`
- `ASMD_Xenpozyme_QSP_v2_0_manuscript.docx` + `.pdf`

**Stage 12 status: COMPLETE — proceed to Stage 13 CPT:PSP paper formatting.**
