Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction: Difference between revisions
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| Document information | |
|---|---|
| Reference | WHO WHO - Guidelines for GCP for trials on
pharmaceutical products* 1995 |
| Validity area | WHO |
| Scope(s) | HM |
| Document name | WHO - Guidelines for GCP for trials on
pharmaceutical products* |
| Version / Revision | 1995 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | World Health Organization
WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products* |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 — Unit 5.1.3 |
| Scope | HM |
| Document part | Glossary - adverse reaction |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Adverse reaction, Definition, Medicinal product |
Content
adverse reaction A response to a pharmaceutical product that is noxious and unintended and which occurs at doses normally used or tested in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, injuries caused by overdosing, abuse or dependence and interactions with any other product should be considered adverse reactions.
