ICH Terms

Adverse Drug Reaction (ADR)

Chief Pharmacist

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting — Step 4 (final); 27 October 1994 — II.A.2 ...

Accuracy

Chief Pharmacist

M10 EWG Bioanalytical Method Validation and Study Sample Analysis — Step 4 (final); 24 May 2022 — Glossary The degree ...

Acceptance Criteria

Chief Pharmacist

Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances — Step ...

Accelerated Testing

Chief Pharmacist

Q1A(R2) Stability Testing of New Drug Substances and Products — Step 4 (final); 6 February 2003 –Glossary Studies designed to ...