Benefit/risk relationship

Therapeutic confirmatory (Phase III) Demonstrate/confirm efficacy Establish safety profile Provide an adequate basis for assessing the benefit/risk relationship to support licensing Establish dose-response relationship Adequate and well controlled studies to establish efficacy Randomized parallel dose-response studies Clinical safety studies Studies of mortality/morbidity outcomes Large simple trials Comparative studies... 

Therapeutic use (Phase III/IV) Refine understanding of benefit/risk relationship in general or special populations and/or environment Identity less common adverse reactions Refine dosing recommendation Comparative effectiveness studies Studies of mortality/morbidity outcomes Studies of additional endpoints Large simple trials Pharmacoeconomic studies... 

Provide an adequate basis for assessing the benefit risk relationship to support licensing Clinical safety studies... 

Clinical data summary and results of statistical analysis Discussion of benefit risk relationship and proposed postmarketing studies... 

I. Discussion of Benefit/Risk Relationship and Proposed Postmarketing Studies... 

Human pharmacokinetics and bioavailability Microbiological summary Clinical summary Benefit/risk relationship... 

If the maximum dose is restricted when the medicine is supplied P or GSL to protect against adverse effects from correct or incorrect use of the medication, it is important to prove that the restricted dose is still as effective and keeps the same benefit-risk relationship, as the original full dose. 

Refine understanding of benefit risk relationship in Comparative effectiveness studies... 

Otway, H.J. Cohen, J.J., Revealed preferences Comments on the Starr benefit - risk relationships. International Institute for Applied Systems Analysis, Research Memorandum RM-75-5, 1975. 

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