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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 ...

Disease

Dyspnoea

Chief Pharmacist

Shortness of breath or difficulty in breathing is a subjective feeling that may or may not be associated with objectively ...

Disease

Heart Failure

Chief Pharmacist

Heart failure (cardiac failure) is not a disease but a syndrome, with many possible aetiologies and a complex pathogenesis, yet ...

Disease

Gallstones

Chief Pharmacist

Gallstones are common, with some 10–15% of adults in Western countries having stones that can be demonstrated by ultrasonography, although ...

Disease

Diarrhea

Chief Pharmacist

Diarrhea is an increased volume or frequency of bowel movement, relative to that normal for an individual, associated with greater ...

ICH Terms

Accuracy

Chief Pharmacist

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

ICH Terms

Acceptance Criteria

Chief Pharmacist

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

ICH Terms

Accelerated Testing

Chief Pharmacist

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

Particle Science

Hausner Ratio

Chief Pharmacist

Hausner ratio is a simplest method to measure powder flow properties. It is a ratio of a powder’s tapped bulk ...

Particle Science

Carr’s Index or Compressibility Index

Chief Pharmacist

Carr’s index is an indicator of the compressibility of powders. It can be determined by measuring both the bulk volume ...

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