Solid-state characterization → formulation → PBPK/BE → regulatory control Decision-support only.... Designed to make wet-lab evidence more focused, faster and audit-ready.
Solid-State Decision Workspace v1.2

Turn material evidence into a defensible development strategy.

Connect active-ingredient form risk, PXRD/DSC/TGA/DVS/PSD interpretation, formulation strategy, dissolution and PBPK/BE translation, stability, and Module 3 control strategy in one reviewable CMC workflow.

Generic developmentCompare RLD and active-ingredient solid-form evidence before formulation, BE, and ANDA commitments.
Innovator developmentSelect and control the developable form with phase-appropriate evidence and risk context.
Program command center

See the decision, risk, and evidence state at a glance.

Start with the integrated view, then move into the specialist workspace needed to resolve the next evidence gap.

Overall risk--

Run intelligence to calculate solid-state formulation risk.

Next experiment--

The highest-value evidence gap will appear here.

Strategy--

Recommended formulation path will appear here.

Decision--

Stage-gate decision will appear here.

Risk map

Not run

Polymorph

--

Moisture

--

Stability

--
Scores are decision-support heuristics to prioritize experiments and control strategy. They do not replace validated analytical methods or wet-lab confirmation.

Next best experiment

Run intelligence to see the highest-value next experiment.

Critical risks

Run executive report to populate critical risks.

Analysis pipeline

Each analysis reports its own state without compressing the scientific workflow.
Evidence-to-decision traceability

Show how the evidence supports the next CMC decision.

Connect reviewed results, assumptions, risk, the stage-gate decision, the next experiment, and regulatory implications.

Decision trace

Run upstream intelligence, then generate the evidence-to-decision trace.

Evidence confidence

Evidence confidence and regulatory implications will appear here.

Persistent CMC project

Store the current inputs, results, status, and characterization evidence as a reviewable solid-state CMC project.

Project response

Create, save, list, or load a project.

Project setup

mg
mg
mg/mL
°C
Comma-separated list. Used for compatibility and formulation strategy scoring.

Workflow logic

What this workbench does

  1. Builds active-ingredient and RLD solid-state profiles and an evidence map.
  2. Interprets characterization evidence: PXRD, DSC/TGA, DVS and PSD.
  3. Prioritizes next experiment using risk and evidence gaps.
  4. Recommends formulation path and risk controls.
  5. Connects solid-state findings to dissolution, PBPK/BE, stability and Module 3 control strategy.

Product guardrails

  • Not a wet-lab replacement.
  • Not a validated medical device.
  • Not a guarantee of BE or regulatory approval.
  • Designed for scientist-in-the-loop, evidence-ranked CMC decision support.

Open evidence intelligence

Run open evidence to retrieve molecule and product context.

Solid-form landscape

Solid-form landscape and polymorph risks will appear here.

Nearest Literature Analog

Not run
Ranks the current API by structural similarity (RDKit Morgan/ECFP4 Tanimoto) against real drugs with well-documented solid-form/polymorphism case studies (ritonavir, carbamazepine, indomethacin, paracetamol, sulfathiazole, cimetidine). A sanity-check benchmark, not a crystal-structure prediction.

Evidence gaps

Evidence gaps populate after executive report.

Characterization data workbench

PXRD / XRD CSV 2θ,intensity
DSC CSV temperature,signal
TGA CSV temperature,mass%
DVS CSV RH%,mass gain%
FTIR / Raman CSVwavenumber,intensity
CIF textcrystal structure
µm
µm
µm

XRD interpretation

Run an XRD analysis to see the diffractogram.
XRD peak table and crystallinity interpretation will appear here.

Thermal / moisture / PSD

Run DSC/TGA to see the thermal curves.
Run DSC/TGA to see the weight-loss curve.
Run DVS to see the moisture sorption curve.
Run PSD to see D10/D50/D90 markers.
DSC/TGA, DVS and PSD findings will appear here.

XRD match / CIF simulation / FTIR-Raman

Run FTIR/Raman to see the spectrum.
Advanced characterization outputs will appear here.

RLD / test PXRD comparability

RLD / reference XRD CSV2theta,intensity
Test product XRD CSV2theta,intensity
%

XRD overlay similarity

Run overlay similarity to see the reference vs test PXRD overlay.
Run overlay similarity to compare matched and extra peaks.

RLD / test product assessment

Run the RLD/test comparison to see the PXRD overlay.
Run the RLD/test comparison to generate a form-match probability and evidence plan.

FDA IID precedent cache

Load or search the IID cache.

Dissolution method precedent

Load or search the dissolution cache.

Next Best Experiment engine

Rank PXRD, DVS, thermal, PSD/dissolution, and compatibility studies by decision value.

Formulation recommender

Run formulation strategy to see ranked formulation path and rationale.

Excipient compatibility

Excipient compatibility risks will appear here.

Dissolution bridge

Dissolution risk bridge will appear here.

PBPK / BE translation risk

PBPK/BE translation risk will appear here.

Formulation candidate comparison

Compare micronized, surfactant-enabled, ASD, and lipid/solubilized formulation strategies.

Generic RLD reverse engineering

RLD comparison, solid-form match strategy and ANDA evidence logic will appear here.

Innovator developability

Innovator form-selection and developability logic will appear here.

QbD CQA/CMA/CPP map

QbD map will appear here.

Regulatory control strategy

Control strategy draft and method package will appear here.

Module 3 solid-state report

Module 3-ready report content will appear here.

Executive Intelligence Report

Generate executive report to see stage-gate decision, risk summary, next experiment and regulatory control strategy.

Evidence package

Generate an evidence package from the current inputs and reviewed results.

Detailed evidence record

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Use the detailed record for validation notes, traceability, and future report generation. Every result should be reviewed by qualified CMC scientists.