Bioanalytical Guidelines and GLP Standards to Support Your Research

Explore a curated collection of bioanalytical guidelines, regulatory requirements and scientific recommendations for GLP bioanalysis, drug development and clinical studies. This resource hub helps ensure methods, studies and regulatory submissions align with current industry standards and expectations.

Bioanalytical Method Validation (BMV)

ICH M10 — Bioanalytical Method Validation (global reference for BMV and sample analysis)

FDA — Bioanalytical Method Validation Guidance for Industry

EMA — Guideline on Bioanalytical Method Validation (+ Q&A/updates)

EMA/FDA — Stability of analytes & handling of incurred sample reanalysis (ISR) (within the BMV frameworks above)

GLP & Quality (Nonclinical)

OECD Principles of GLP — (Series on Principles of GLP and Compliance Monitoring)
OECD No. 17 — Application of GLP Principles to Computerised Systems
FDA 21 CFR Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies
GAMP 5 — A Risk-Based Approach to Compliant GxP Computerized Systems (incl. 2nd edition)

Analytical Procedures (fit-for-purpose / CMC)

ICH Q2(R2) — Validation of Analytical Procedures (analytical performance characteristics)
ICH Q14 — Analytical Procedure Development (lifecycle approach, method understanding)
ICH Q8–Q10 — Pharmaceutical Development, Quality Risk Management, Pharmaceutical Quality System (for broader CMC context)

Pharmacokinetics / Bioequivalence

EMA — Guideline on the Investigation of Bioequivalence (+ product-specific annexes/Q&A)
FDA — 21 CFR Part 320 (Bioavailability and Bioequivalence Requirements) + product-specific BE guidances
ICH E11A — (pediatric extrapolation; when relevant for PK strategies)

Clinical (GCP & General Considerations)

ICH E6 (GCP) — Current version (and E6(R3) when finalized
ICH E8(R1) — General Considerations for Clinical Studies
ICH E9 — Statistical Principles for Clinical Trials
FDA/EMA — Trial conduct, electronic records/signatures (e.g., 21 CFR Part 11), and oversight guidance

Nonclinical Safety (context for TK/Exposure)

ICH M3(R2) — Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization
ICH S-series (as applicable) — e.g., S7B/E14 (QT prolongation, concentration–response integration)

How we use these guidelines

Development → Validation → Routine Analysis fully mapped to ICH M10 and GLP

Computerised systems & data integrity aligned with OECD 17 and GAMP 5

Bioequivalence studies aligned with EMA BE and FDA BE frameworks

Documentation built for regulatory submissions (FDA/EMA/other agencies)