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[Klaus Meier]

Was meint ihr - was ist hier noch drin ?

25.08.03 19:41 Uhr

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[Klaus Meier]

http://www.metabolic.com.au/

Drug Pipeline Chart
Product Description Lead Indication
AOD9604 Fat metabolism hGH fragment Obesity

Pre Clinical Efficacy Pre Clinical Safety Phase I Phase II Phase III On Market



Product Description Lead Indication
ADD9918/22 Sugar metabolism insulin fragment Type 2 diabetes

Pre Clinical Efficacy Pre Clinical Safety Phase I Phase II Phase III On Market



Product Description Lead Indication
MBP0250/60 Bone metabolism amylin/adrenomedullin fragment Osteoporosis

Pre Clinical Efficacy Pre Clinical Safety Phase I Phase II Phase III On Market



Product Description Lead Indication
MBP0201 Iron metabolism vitamin B analog Iron overload

Pre Clinical Efficacy Pre Clinical Safety Phase I Phase II Phase III On Market




A compound is first `discovered`, often in a University, and then taken through the pre-clinical phase. During the pre-clinical stages of drug development, investigators have to produce a comprehensive set of data regarding drug safety (toxicology) and activity (efficacy). This is achieved by testing the effect of the drug in living organisms (in vivo) and in cells in the test tube (in vitro). Results of all testing must be provided to regulatory agencies for review.

The next phase are the clinical trials. Moving drug development to the human trial stage represents a major milestone for the drug developer.

Clinical testing usually consists of Phase I, Phase II and Phase III clinical studies.
Phase I Clinical Studies: Short term study designed to verify safety and tolerability of the candidate drug in humans.
Phase II Clinical Studies: To determine the effectiveness of the drug and further study its safety in humans.
Phase III Clinical Studies: Phase III studies provide long term testing of effectiveness and safety of the drug. Testing is conducted over at least a year with several hundred patients and is therefore expensive.

Marketing proposals, large scale manufacture and all the other things needed for market release are usually organised at the same time Phase III studies are underway.