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AZN » Topics » Phase IV

This excerpt taken from the AZN 20-F filed Mar 12, 2008.
phase I The phase of clinical research where a new drug or treatment is tested in small groups of people (twenty to eighty) to check that the drug can achieve appropriate concentrations in the body and, determine a safe dosage range, and identify side effects. This phase includes healthy volunteer studies.
phase II This phase of clinical research includes the controlled clinical activities conducted to evaluate the effectiveness of the drug in patients with the disease under study and to determine the common short-term side effects and risks associated with the drug. Phase II studies are typically conducted in a relatively small number of patients (usually no more than several hundred).
phase III This phase of clinical research is performed to gather additional information about effectiveness and safety of the drug, often in a comparative setting, to evaluate the overall benefit/risk profile of the drug. Phase III studies usually include between several hundred and several thousand patients.
This excerpt taken from the AZN 6-K filed Mar 7, 2008.
phase I The phase of clinical research where a new drug or treatment is tested in small groups of people (twenty to eighty) to check that the drug can achieve appropriate concentrations in the body and, determine a safe dosage range, and identify side effects. This phase includes healthy volunteer studies.
phase II This phase of clinical research includes the controlled clinical activities conducted to evaluate the effectiveness of the drug in patients with the disease under study and to determine the common short-term side effects and risks associated with the drug. Phase II studies are typically conducted in a relatively small number of patients (usually no more than several hundred).
phase III This phase of clinical research is performed to gather additional information about effectiveness and safety of the drug, often in a comparative setting, to evaluate the overall benefit/risk profile of the drug. Phase III studies usually include between several hundred and several thousand patients.
This excerpt taken from the AZN 20-F filed Mar 27, 2007.
Phase IV – Post-marketing studies to delineate additional information about the drug’s risks, benefits and optimal use, including those that may be requested by regulatory authorities in conjunction with marketing approval.
This excerpt taken from the AZN 6-K filed Mar 6, 2007.
Phase IV – Post-marketing studies to delineate additional information about the drug’s risks, benefits and optimal use, including those that may be requested by regulatory authorities in conjunction with marketing approval.
This excerpt taken from the AZN 6-K filed Jul 10, 2006.

Phase III

Compound Mechanism Area under
investigation		 Phase Estimated Filing 
MAA NDA
CV          
AGI-1067 Anti-atherogenic atherosclerosis III 1H 2007 1H 2007
AZD6140 ADP receptor antagonist arterial thrombosis III >2008 >2008
Neuroscience          
NXY-059 free radical trapping agent stroke III 1H 2007 1H 2007
Oncology/Inf          
Zactima VEGF/EGF TKI inhibitor with RET kinase activity NSCLC III >2008 >2008
AZD2171 VEGF signalling inhibitor (VEGFR-TKI) NSCLC and CRC II/III >2008 >2008





EXCERPTS ON THIS PAGE:

20-F
Mar 12, 2008
6-K
Mar 7, 2008
20-F
Mar 27, 2007
6-K
Mar 6, 2007
6-K
Jul 10, 2006

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"Phase IV" elsewhere:

Amgen (AMGN)
Array BioPharma (ARRY)
Centene (CNC)
Theravance (THRX)
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