Medicines and Risk/Benefit Decisions
The third CMR Workshop prov. ided the opportunity for a group of experts from the Industry, academia and the regulatory authorities to meet and discuss ways and means by which risk benefit decisions are made during the various stages of drug development. It became apparent from the discussions that...
| Other Authors: | , |
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| Format: | eBook |
| Language: | English |
| Published: |
Dordrecht
Springer Netherlands
1987, 1987
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| Edition: | 1st ed. 1987 |
| Series: | CMR Workshop Series
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| Subjects: | |
| Online Access: | |
| Collection: | Springer Book Archives -2004 - Collection details see MPG.ReNa |
Table of Contents:
- Introductory Remarks
- Session 1 Risks in Perspective
- 1.1 The risks in society
- 1.2 The risks from diseases
- 1.3 Perception of risk
- Session 2 Assessing the Risks from Medicines
- 2.1 Risk predicted from animal studies
- 2.2 The risk identified from clinical trials
- 2.3 The risk determined from PMS studies
- Session 3 Measuring the Benefits of Medicines
- 3.1 Clinical benefits
- 3.2 Economic benefits
- 3.3 Psycho-social benefits
- Session 4 Risk-Benefit Decisions
- 4.1 Risk-benefit decisions in human administration
- Discussant
- 4.2 Risk-benefit decisions in product licence application
- Disscussant
- 4.3 Risk-benefit decisions in licensing changes
- Discussant
- 4.4 Risk-benefit decisions in patient care
- Discussant
- Discussant