GxP Compliant Environment

Pharma Lab

End-to-end pharmaceutical simulations: PK/PD, clinical trials, formulation, bioprocessing, regulatory, and health economics. The most in-demand sim suite in life sciences.

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01Free
Preclinical — PK

Two-Compartment PK Model

IV bolus, infusion, and oral absorption with first-order elimination. Real-time plasma concentration-time curves, Cmax, Tmax, AUCinf, clearance, and volume of distribution.

AUCClearanceVdHalf-life
02Free
Preclinical — PD

Emax Dose-Response

Sigmoidal Emax model with Hill coefficient, EC50, and IC50. Watch receptor occupancy shift as you titrate agonist, antagonist, or allosteric modulator concentrations.

EC50Hill SlopeReceptorOccupancy
03Free
Preclinical — ADME

ADME / BCS Prediction

Lipinski's Rule of Five, logP, solubility, permeability, and BCS classification. First-pass hepatic extraction and bioavailability fraction update in real-time as you modify the molecule.

LogPPermeabilityBCS ClassFgut
04Free
Clinical — BE

Bioequivalence Crossover Study

2×2 crossover design with TOST procedure. Real-time 90% CI calculation for Cmax and AUC, intra-subject CV, and sample size power curve as you adjust bioavailability delta.

90% CITOSTCVwPower
05Free
Manufacturing — QC

In Vitro Dissolution / f2 Factor

USP I basket and USP II paddle apparatus. Adjust paddle speed, media pH, and ionic strength. Real-time f2 similarity factor calculation for biowaiver justification.

USP IIf2 FactorBiowaiverQ
06Free
Manufacturing — Solid Dose

Tablet Compression Force

Heckel and Kawakita analysis of compression force vs. porosity. Real-time hardness, friability, and disintegration time prediction as you adjust punch pressure and dwell time.

HeckelHardnessFriabilityDwell Time
07🔒 Pro
Manufacturing — Stability

Accelerated Stability / Arrhenius

Temperature and humidity stress with Arrhenius degradation kinetics. Predict shelf life (t90), activation energy, and expiry date from accelerated data in real-time.

Arrheniust90Activation EExpiry
08🔒 Pro
Manufacturing — Analytical

HPLC Method Development

Column chemistry selection, mobile phase gradient, and flow rate optimization. Real-time resolution (Rs), tailing factor (Tf), theoretical plates (N), and pressure drop.

ResolutionTailingPlatesGradient
09🔒 Pro
Manufacturing — Sterile

Aseptic Process Simulation

Media fill run with contamination probability modeling. Grade A/B airflow visualization, operator intervention risk, and particle monitoring with alert/action limits.

Media FillGrade AContaminationISO 5
10🔒 Pro
Manufacturing — Lyophilization

Freeze-Drying Cycle Design

Primary and secondary drying with collapse temperature (Tc) monitoring. Sublimation rate, chamber pressure, and cake resistance update as you ramp shelf temperature.

TcSublimationShelf TempMoisture
11🔒 Pro
Manufacturing — Bioprocess

Bioreactor Fed-Batch Culture

CHO or HEK293 cell culture with glucose feed, lactate shift, and viable cell density tracking. Real-time titer, specific productivity (Qp), and perfusion rate optimization.

VCDQpGlucoseTiter
12🔒 Pro
Manufacturing — DSP

Downstream Purification (AKTA)

Protein A capture, ion exchange, and hydrophobic interaction chromatography. Real-time yield, purity, HCP and DNA clearance, and column lifetime tracking.

Protein AHCPYieldResin
13🔒 Pro
Preclinical — Formulation

Solubility Enhancement

Salt screening, co-solvent, surfactant, and amorphous solid dispersion strategies. Real-time supersaturation index, thermodynamic vs kinetic solubility, and precipitation risk.

ASDSupersaturationCo-solventBiorelevant
14🔒 Pro
Preclinical — Toxicology

Toxicology Dose Escalation

MTD, NOAEL, and safety margin determination with allometric scaling. TK evaluation, dose-proportionality assessment, and toxicokinetic safety window visualization.

NOAELAllometryTK/TKSafety Margin
15🔒 Pro
Clinical — Operations

Clinical Trial Enrollment

Patient recruitment curve with dropout modeling, interim analysis triggers, and adaptive design gates. Real-time power curve and sample size re-estimation.

DropoutInterimAdaptivePower
16🔒 Pro
Clinical — PK/PD

Population PK/PD (NLME)

NONMEM-style nonlinear mixed-effects modeling. Covariate effects on CL and V, ETA distribution, VPC, and bootstrap confidence intervals in real-time.

NONMEMCovariateVPCBootstrap
17🔒 Pro
Regulatory — Biosimilars

Biosimilar Analytical Similarity

Tier 1 critical quality attributes with equivalence margin testing. Analytical similarity index, immunogenicity risk scoring, and fingerprint comparison.

Tier 1EquivalenceImmunogenicityFingerprint
18🔒 Pro
Manufacturing — QbD

Design of Experiments (DoE)

Full factorial, fractional factorial, and response surface methodology. Design space boundary, normal operating range (NOR), and proven acceptable range visualization.

RSMDesign SpaceNORPAR
19🔒 Pro
Manufacturing — PAT

Process Analytical Technology

NIR spectroscopy with multivariate PLS models. Real-time assay, content uniformity, and moisture prediction with control chart limits for RTRT.

NIRPLSRTRTControl Chart
20🔒 Pro
Regulatory — Submission

eCTD Assembly & Validation

Module 1–5 structure assembly with lifecycle management. Real-time validation against ICH eCTD 4.0 spec, hyperlink checking, and PDF technical compliance.

Module 3LifecycleValidationICH M4
21🔒 Pro
Regulatory — PV

Pharmacovigilance Signal Detection

Disproportionality analysis with PRR, ROR, and IC calculation. Temporal pattern scanning, case triage priority scoring, and regulatory threshold alerts.

PRRRORICSignal
22🔒 Pro
Manufacturing — Supply Chain

Cold Chain & GDP Logistics

Temperature excursion mapping across distribution lanes. Thermal packaging qualification, stability budget burn rate, and GDP compliance deviation tracking.

TemperatureExcursionGDPStability Budget
23🔒 Pro
Economics — HTA

Health Economics / QALY Model

Markov state-transition model with Monte Carlo microsimulation. QALY accumulation, incremental cost-effectiveness ratio (ICER), budget impact, and tornado sensitivity.

QALYICERMarkovTornado
24🔒 Pro
Preclinical — Biologics

Antibody-Drug Conjugate (ADC)

DAR distribution modeling, payload release kinetics, and bystander effect radius. Therapeutic index window and off-target toxicity probability in real-time.

DARPayloadBystanderTI
25🔒 Pro
Manufacturing — mRNA

mRNA-LNP Manufacturing

In vitro transcription, enzymatic capping, and LNP microfluidic encapsulation. Real-time encapsulation efficiency, particle size (DLS), integrity, and potency tracking.

IVTLNPEncapsulationPotency

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