Disclaimer & Legal Notice

Please read the following terms carefully before using the PK-NCA Suite.

1. General Disclaimer

PK-NCA Suite is provided "as is" without warranty of any kind, express or implied. The software is intended for educational, research, and exploratory purposes only. It is NOT a validated software system under 21 CFR Part 11 or any regulatory framework and should NOT be used as the sole basis for regulatory submissions, clinical decisions, or patient care.

Users assume all responsibility for verifying the accuracy and appropriateness of any results generated by this tool. The developers accept no liability for any direct, indirect, incidental, or consequential damages arising from the use of this software.

2. Scientific Basis & Originality

All pharmacokinetic calculations implemented in PK-NCA Suite are derived from publicly available textbook knowledge and peer-reviewed scientific literature, including but not limited to:

  • Gabrielsson J, Weiner D. Pharmacokinetic & Pharmacodynamic Data Analysis. 5th ed. 2016. — Primary source for trapezoidal integration formulae, AUMC, and MRT calculations.
  • Rowland M, Tozer TN. Clinical Pharmacokinetics and Pharmacodynamics. 4th ed. 2010. — Standard NCA parameter definitions.
  • Gibaldi M, Perrier D. Pharmacokinetics. 2nd ed. 1982. — Classical derivation of the linear-up log-down method.
  • Wagner JG. Fundamentals of Clinical Pharmacokinetics. 1975. — Terminal phase regression methodology.

The mathematical formulae (linear trapezoidal rule, log-linear trapezoidal rule, AUMC integrals, terminal elimination rate constant regression, etc.) are well-established, universally taught, and not proprietary to any software vendor. They represent fundamental pharmacokinetic science available in any standard PK textbook.

3. No Reverse Engineering

PK-NCA Suite is an independent, original implementation of standard pharmacokinetic analytical methods. It was built from first principles using publicly available scientific literature and mathematical derivations.

This software is NOT a reverse-engineered copy, derivative, or emulation of any proprietary pharmacokinetic software product. No proprietary source code, object code, algorithms, or trade secrets from any commercial software vendor were accessed, decompiled, disassembled, or otherwise used in the development of PK-NCA Suite.

Any similarities in computational results between PK-NCA Suite and commercial software products arise solely from the shared use of standard mathematical formulae published in the scientific literature, which are not proprietary to any vendor.

4. Validation & Accuracy

PK-NCA Suite includes an automated validation benchmark that compares computed NCA parameters against published reference values using the Theophylline Subject 1 standard dataset.

  • Reference values are sourced from published pharmacokinetic textbooks, not from any proprietary software.
  • The benchmark is provided for transparency and reproducibility, not as evidence of regulatory validation.
  • Users performing regulatory analyses should independently verify results using validated software and established SOPs.

5. Data Privacy & Security

  • All computations are performed entirely within the user's web browser. No pharmacokinetic data, patient data, or study data is transmitted to any external server.
  • No data is collected, stored, logged, or shared by the application.
  • No analytics, tracking, or telemetry services are used.
  • No API keys, user accounts, or authentication is required.
  • Users can verify this by inspecting network traffic in their browser's developer tools.

6. Regulatory Status

PK-NCA Suite is NOT:

  • A medical device or software as a medical device (SaMD)
  • FDA-cleared, CE-marked, or approved by any regulatory authority
  • Validated under 21 CFR Part 11 or Annex 11 (GxP compliance)
  • Suitable for use in regulated clinical trial data analysis without independent validation
  • A substitute for commercially validated pharmacokinetic analysis software in regulatory settings

7. Intellectual Property & Trademarks

All trademarks, registered trademarks, and brand names mentioned in the scientific literature references are the property of their respective owners. Their mention in citations is solely for academic attribution and does not imply any endorsement, affiliation, or association with PK-NCA Suite.

PK-NCA Suite uses the following open-source libraries under their respective licenses: D3.js (BSD), SheetJS (Apache 2.0), Font Awesome (CC BY 4.0 / SIL OFL), Inter font (SIL OFL), JetBrains Mono (SIL OFL).

8. Limitation of Liability

To the maximum extent permitted by applicable law, the developers of PK-NCA Suite shall not be liable for any:

  • Errors, inaccuracies, or omissions in computed results
  • Clinical decisions, regulatory submissions, or actions taken based on the output
  • Loss of data, profits, or business opportunities
  • Damages arising from software bugs, browser compatibility issues, or computational limitations
  • Consequences of using the software for purposes it was not designed for

9. Intended Use

PK-NCA Suite is designed for:

  • Education: Teaching and learning pharmacokinetic analysis methods
  • Research: Exploratory PK data analysis and rapid hypothesis testing
  • Visualization: Publication-quality graph generation
  • Cross-validation: Verifying computations from other software

It is NOT intended for direct use in clinical trial reporting to regulatory agencies without independent verification by a validated system.

Last updated: February 2026. This disclaimer may be updated periodically.
By using PK-NCA Suite, you acknowledge that you have read and agree to these terms.