Basic Drug Pipeline Data (cont'd)
Development Status
Developmental milestones recorded in pipeline directories include both scientific and government-mandated stages in a compound's progress from laboratory to launch.
Stages identified and keywords used to describe them may differ from directory to directory.
In the section on Drug R&D Process Overview we reviewed the major steps in the drug development process.
The most frequently used status terms are listed below. As you will see, different additional development status terminology may be used in each pipeline directory.
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Preclinical
Phase I
Phase II
Phase III
Registered (term used to indicate "Approval")
Launched (term used to indicate the drug is being marketed)
The excerpt below from Adis R&D Insight (Dialog File 107) is an example of how status information is represented.
Figure 6: Excerpt from Adis R&D Insight
5/9/1 DIALOG(R)File 107: Adis R&D Insight (c) 2007 Adis Data Information BV. All rights reserved. 00240128 012103 Drug Name: Vatalanib Record Revision Date: 20061229 Synonyms: CGP 79787; PTK 787; PTK/ZK; PTK787; ZK 222584
(portion of record omitted)
Highest Phase: Phase III Development Status: Phase III, Switzerland, Colorectal cancer Phase III, USA, Colorectal cancer Phase II, Switzerland, Age-related macular degeneration Phase II, Italy, Glioblastoma Phase II, Netherlands, Glioblastoma Phase II, France, Non-small cell lung cancer Phase II, Germany, Non-small cell lung cancer Phase II, Switzerland, Solid tumours Phase II, USA , Solid tumours Phase I, Germany, Colorectal cancer Phase I, Germany, Glioblastoma Phase I, Germany, Ovarian cancer Phase I, Germany, Renal cancer Phase I, Switzerland, Renal cancer Preclinical, USA, Multiple myeloma
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