BayesGenRx

RLD Intelligence Studio
Checking platform Program OS Regulatory-ready Audit trail Guided workflow
Measurement-first reference product intelligence

Understand the reference product. Narrow the formulation space.

Turn laboratory observations into a defensible formulation target space, expose what is still unknown, and direct the next experiment. Measurements stay distinct from assumptions and model inference; uncertainty is shown rather than hidden.

Measuredlot + method + unit + basis + uncertainty
Unknownstays unknown until evidence resolves it
Hypothesesseparate from observations and review decisions
Next experimentexplicit question, purpose and stop condition
ProgramSelect Program OS record
Reference—
Strength—
Dosage form—
Route / release—
Evidence stateNo reviewed evidence

Scientific context

Exact programme/reference basis and current route-specific capability boundary.

Product-family pack

Only qualified route-specific depth is activated.

Decision brief

What is established, what remains ambiguous, which candidates remain feasible and what should happen next.

Established for this use

Uncertainty

Unknown

Evidence copilot

Bounded, evidence-linked explanations only. It cannot invent measurements, confidence percentages or accepted claims.
Choose a bounded question. Every answer will expose the evidence/run identifiers it relies on.

Controlled laboratory import

Preview CSV/XLSX before commitment: column mapping, units, duplicates, missing metadata and original values remain visible.
preview → review → commit
Select a controlled laboratory file to preview. Nothing is committed during preview.

Manual measurement intake

Record the observed value and its scientific context. Acceptance is a separate authorized review.
select a Program OS record
Acceptance cannot be selected here. A reviewer must first qualify the analytical method, then separately accept the observation. Measurement validity and target compliance are independent decisions.

Method qualification

Fit-for-purpose state is explicit and reviewer controlled.

Evidence Inspector

Trace measurement → method → review → raw evidence. Invalid methods cannot establish sameness.
0 accepted for reuse

Add formulation constraint

Preserve units/basis and source meaning; no auto-balancing.

Candidate reconstruction space

Joint feasibility, mass closure, candidate-specific material grades and exact source constraints.
not an “exact innovator formula”

Constraint review queue

Reviewer acceptance is required before a constraint narrows the target space.

Competing hypothesis

Record a falsifiable process/structure hypothesis, not a conclusion.

Hypothesis set

Support, contradiction, predicted consequence and discriminatory experiment remain inspectable.

Structure / spatial evidence

Solid-state, PSD, morphology, porosity and spatial records can be linked without claiming more than the method supports.

Next experiment queue

Transparent prioritisation by decision impact and uncertainty before advanced value-of-information scoring.
scientist reviewed

Record selected experiment

Capture the scientist’s choice, sample budget and stop rule.

Experiment decisions

Completed/failed work can return to the evidence ledger and change the target space transparently.

Comparative performance

Reference/test profiles by lot, condition and timepoint with variability.

Applicability gate

Statistics are secondary to method qualification and aligned experimental context.

Reference variability

Lot-aware descriptive summaries with explicit sample adequacy. No unidentifiable variance component is invented.
Boundary: Similar dissolution can support a comparative-performance argument when applicable, but it does not identify a unique formulation and does not automatically establish bioequivalence.

Controlled reconstruction run

Freeze exact evidence, methods, target-space constraints, source versions and engine version.

Versioned handoffs

Downstream work receives a locked evidence package—not an upgraded scientific claim.

Laboratory systems

Reuse the controlled PR23 ingestion boundary rather than creating a parallel connector.

Handoff & memo history

Input hashes and stale-state propagation remain inspectable.

Collaboration & review queue

Anchor requests to a scientific object and enforce independent assignment when required.
Opportunity score
—
Run assessment
Submission readiness
—
Stage gate
Evidence issues
—
Highest risk
Regulatory clarity
—
Pathway confidence
BE probability
—
Study design
Launch feasibility
—
Patent feasibility

Boardroom Decision

Decision, rationale, risks and stage-gate recommendation.
not assessed
Run Full Product Assessment to generate a decision.

Next Gate

What the team should do before the next investment decision.
actionable

RLD & Sameness

Formulation target space and Q1/Q2/Q3 status.

Evidence Gaps

Top blockers before the next stage.

Best Launch Path

Risk-adjusted strategy option.

Guided Workflow

From molecule triage to submission package.

Stage-Gate Action Board

Regulatory, formulation, BE, analytical, patent and commercial workstreams.
pending

Evidence Map

How scientific, regulatory, patent and commercial evidence connects.

Evidence Reconciliation

Flags contradictory or incomplete evidence.

Source Confidence

Data availability and confidence across connected intelligence sources.

Product-Specific Guidance

Regulatory pathway, waiver strategy and study expectations.

Regulatory Gap Map

High-impact regulatory gaps before BE protocol lock.

FDA Interaction Strategy

Meeting need, packet and owner map.

Agency Question Builder

Structured questions and submission checklist.

BE Study Simulator

Sample size, dropout adjustment, pass probability and study risks.

BE Sensitivity

CV, T/R ratio and sample-size sensitivity.

Dissolution Similarity

f2 comparison for in vitro performance.

BE Confidence Interval Check

Checks whether 90% CI assumptions fit the expected window.

RLD Lab Plan

Assays, techniques, sample strategy and priorities.

Analytical Method Plan

Assay, dissolution, excipient quantitation, PSD and solid-state methods.

Validation Matrix

Specificity, accuracy, precision, linearity, robustness and documentation.

Prototype Design Plan

CQA/CPP factors, responses and batch plan.

Patent Estate

Patent classes, challenge difficulty and strategy.

Launch Scenarios

Wait, challenge, settlement, design-around or avoid/watch.

Scenario Simulator

Readiness-adjusted value and portfolio decision.

Portfolio Ranking

Prioritize multiple generic opportunities.

Molecule Comparison

Compare two opportunities side by side.

Management Report

Decision memo, regulatory plan, patent strategy, lab plan and readiness summary.

Public Evidence Links

Regulatory and public source links for follow-up review.
BayesGenRx is a decision-support system. Confirm with measured RLD lab work, validated BE statistics, CMC/regulatory review and patent counsel.

Scientific review

Record the actual rationale, restrictions and downstream effect.