PUBLIC SCIENTIFIC WORKFLOW DEMONSTRATION
Follow the question. Inspect the evidence.
Explore seven stages of an illustrative immediate-release oral-tablet programme. Every step makes the input, evidence gap and next accountable reviewer visible.
Illustrative only: No real study results, private programme records or regulatory approvals are represented.
GX-SAMPLE-01 Oral tablet · standard generic development Illustrative sample data
01 Reference product02 Formulation03 MIDD / vBE04 Transfer & stability05 Quality06 Regulatory07 Decision packet
GX-SAMPLE-01 · Reference product What is observed, and what is still a hypothesis?
Input Reference observations and a retrieved source record.
Evidence / output The excipient role is a hypothesis. The quantitative range is unverified. A solid-state comparison is missing. Sample evidence record RLD matrix · r1 Review required
Next accountable action Plan the solid-state characterization experiment. Formulation scientist
GX-SAMPLE-01 · Formulation Which candidate should move to an experiment?
Input RLD matrix r1 and two illustrative candidate rationales.
Evidence / output Candidate A needs dissolution evidence. Candidate B needs compatibility evidence. Neither candidate is selected for production. Sample evidence record Candidate comparison · r1 Review required
Next accountable action Agree the dissolution and compatibility experiment plan. Formulation & analytical reviewers
GX-SAMPLE-01 · MIDD / vBE Which uncertainty matters for this development question?
Input Candidate evidence, declared model context and analysis assumptions.
Evidence / output The model plan records dissolution and physiology assumptions. This preview contains no simulated PK result or regulatory BE conclusion. Sample evidence record Model review record · r1 Review required
Next accountable action Review model applicability before running the performance comparison. Independent modelling reviewer
GX-SAMPLE-01 · Transfer & stability What needs review before the process changes?
Input Candidate rationale and a proposed equipment change.
Evidence / output Equipment fit and process sensitivity need assessment. Stability context needs updating before the transfer evidence can be reviewed. Sample evidence record Transfer assessment · r1 Review required
Next accountable action Define the comparability checks and stability review. MSAT & stability reviewers
GX-SAMPLE-01 · Quality What does the proposed change affect?
Input Change proposal linked to candidate and transfer evidence.
Evidence / output The investigation records an evidence gap. The proposed CAPA remains a draft. QA reviews the supporting record and affected work. Sample evidence record Quality change assessment · r1 Review required
Next accountable action Review the investigation and proposed action with QA. Authorized quality reviewer
GX-SAMPLE-01 · Regulatory Which claim needs to be refreshed?
Input Source update and a Module 3 narrative linked to evidence r1.
Evidence / output The affected development claim is marked for review. The revised narrative remains a draft with the evidence gap visible. Sample evidence record Claim-to-source record · r2 Review required
Next accountable action Reconcile the source update and revise the narrative. Regulatory reviewer
GX-SAMPLE-01 · Decision packet What is ready for the next accountable review?
Input Versioned evidence references and unresolved questions from this sample.
Evidence / output The packet lists owners, evidence versions, model context and open gaps. It is a review draft; no approval or filing readiness is inferred. Sample evidence record Review packet · draft r1 Review required
Next accountable action Assign the remaining reviews and record the decision. Programme lead
Public, read-only illustration. Transitions explain the workflow; they do not execute module handoffs or load client records.