TAKEDA R&D

1 TAKEDA . R&D. PROFESSIONAL FILE. 540-8645 1 1 TEL : 06-6204-2111. 103-8668 12 10 TEL : 03-3278-2111. 2015 4 . Published in April 2015.. Ltd.. Inc.. Limited . Pharma A/S .. 70 .. Inc.. Inc. Maltilab Ind . ustria e CMC Com ercio de Produtos . Farmac euticos Ltda. 1 9 GmbH. Inc. Inc. Ltd. Co. Inc. Pte. Ltd. Inc.. Pte. Ltd. Pte. Limited . Co., Ltd.. CMC .. 02 TAKEDA R&D Professional File TAKEDA R&D Professional File 03.. P6 P8. P10 P12 CMC . P14 P16. P18 P20 . P22 P24 .. STEP1 STEP2 STEP3 STEP4.. STEP1 .. CMC . 04 TAKEDA R&D Professional File TAKEDA R&D Professional File 05.. [ ]. [ ] .. TV . 3 .. 1 .. 4 .. 6 .. 2009 .. [ ]. [ ] .. QOL(Quality of Life) .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers 6 .. 06 TAKEDA R&D Professional File TAKEDA R&D Professional File 07.. [ ] .. [ ].. MOA .. 2009 .. [ ] .. GPT . [ ]. Global Project Team .. in vitro .. MOA (Mode of Action: ) . 1.

2 Q1 Q2 Q3 Q4 Q5.. Questions & Answers PI3K-Akt 1 .. 08 TAKEDA R&D Professional File TAKEDA R&D Professional File 09.. GMP .. [ ]. 3 .. 3 .. [ ].. GMP .. CMC 2010 .. [ ] [ ] .. 1 .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers 2 4 .. 10 TAKEDA R&D Professional File TAKEDA R&D Professional File 11.. 3 .. [ ].. 3 .. [ ] .. CMC 2007 .. [ ].. [ ] .. 4 6 .. 3 .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers .. 12 TAKEDA R&D Professional File TAKEDA R&D Professional File 13.. [ ].. [ ] . 4 .. 1 .. 4 3 . GMP( ) .. 4 .. 1 .. 1 CMC .. [ ].. 2009 .. [ ] .. CMO.. 2 .. CMC.. 2 .. CMO .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers - 2 .. 1 10km .. 14 TAKEDA R&D Professional File TAKEDA R&D Professional File 15.. [ ]. [ ]. 1 .. 1 .. 1 .. 2010 2 .. [ ] [ ].. CMC.. 1 .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers .. 16 TAKEDA R&D Professional File TAKEDA R&D Professional File 17.. [ ].. [ ] . 2020 .. 3 .. 2.

3 1 .. 3 .. 2010 .. [ ]. [ ] .. 2012 .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers 1 NPO 3 .. 18 TAKEDA R&D Professional File TAKEDA R&D Professional File 19.. [ ].. CRO .. [ ].. 5 9 . 4 .. 9 .. 2006 .. [ ] [ ] .. PMDA .. PMDA . 1 .. 1 10 20 .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers CM CRO 1 5km .. 20 TAKEDA R&D Professional File TAKEDA R&D Professional File 21.. [ ] .. [ ].. 1 .. 2 IT .. 2009 .. [ ] [ ] .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers 2 .. 22 TAKEDA R&D Professional File TAKEDA R&D Professional File 23.. [ ]. [ ]. 3 .. 5 . 3 .. 1 .. 3 .. 2008 .. [ ] . [ ] .. 3 .. 3 .. 3 .. 1 .. CRO .. Q1 Q2 Q3 Q4 Q5.. Questions & Answers . 1 .. 24 TAKEDA R&D Professional File TAKEDA R&D Professional File 25.. R&D . OJT . OJT .. R&D 4 . 1200 .. OJT Off-JT off-JT . 4 off-JT .. 1970 .. 1915 1914 . 2012 .. LIME* . 5 .. 21 CO2 .. CMC . Life-cycle impact assessment Method based on Endpoint modeling.

4 2013 2013 . CO2 .. 2005 2010 . 21% 26% .. 1946 .. 26 TAKEDA R&D Professional File TAKEDA R&D Professional File 27.