RESEARCH METHODOLOGY
Patient Analog.com content is compiled from primary sources including regulatory agency publications, peer-reviewed scientific literature, company press releases and SEC filings, and established market research reports. All market projections represent ranges from multiple analyst sources.
📜 REGULATORY SOURCES
US FEDERAL
- FDA Modernization Act 2.0 — Public Law 117-328, Section 3209 (December 29, 2022)
- FDA Modernization Act 3.0 — S.2366 (Senate passed December 16, 2025)
- FDA ISTAND Pilot Program Guidance Documents
- NIH NCATS Tissue Chip for Drug Screening Program Documentation
- ARPA-H Program Announcements and Award Documentation
EUROPEAN UNION
- EMA Regulatory Science Strategy to 2025
- Directive 2010/63/EU on Protection of Animals Used for Scientific Purposes
- Horizon Europe CPBT and UNLOOC Grant Documentation
📚 KEY SCIENTIFIC PUBLICATIONS
FOUNDATIONAL PAPERS
- Huh D, et al. "Reconstituting Organ-Level Lung Functions on a Chip." Science 328, 1662-1668 (2010) — First lung-on-chip
- Sato T, et al. "Single Lgr5 stem cells build crypt-villus structures in vitro without a mesenchymal niche." Nature 459, 262-265 (2009) — First intestinal organoids
- Lancaster MA, et al. "Cerebral organoids model human brain development and microcephaly." Nature 501, 373-379 (2013) — First brain organoids
- Takahashi K, Yamanaka S. "Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures." Cell 126, 663-676 (2006) — iPSC discovery
VALIDATION STUDIES
- Emulate Liver-Chip ISTAND submission data (2024) — 87% sensitivity, 100% specificity for hepatotoxicity
- Tumor organoid clinical validation studies — >87% drug response prediction accuracy
🏢 COMPANY SOURCES
- SEC filings (10-K, S-1, 8-K) for public companies: HeartFlow, Recursion, Schrödinger, Certara, Simulations Plus
- Crunchbase, PitchBook, CB Insights for private company funding data
- Company press releases via PR Newswire, Business Wire, GlobeNewswire
- Official company websites and investor presentations
📊 MARKET RESEARCH SOURCES
Market size projections represent consensus ranges from multiple analyst reports. Specific figures may vary by source due to different market definitions and methodologies.
- Grand View Research — Organ-on-Chip, Organoid, Digital Twin market reports
- Markets and Markets — MPS, AI Drug Discovery market analysis
- Frost & Sullivan — Healthcare digital transformation reports
- McKinsey, BCG, Deloitte — Life sciences industry analysis
DISCLAIMER
Patient Analog.com provides educational content about human simulation technologies. Information is compiled from public sources believed to be reliable but is not guaranteed for accuracy or completeness. Market projections are forward-looking and subject to change. This site does not provide investment, medical, or legal advice. For acquisition inquiries, contact [email protected].