-
5
-
-
84873364557
-
Pharmacogenetics in the evaluation of new drugs: A multiregional regulatory perspective
-
doi: 10.1038/nrd3931
-
Maliepaard M, Nofziger C, Papaluca M, Zineh I, Uyama Y, Prasad K, Grimstein C, Pacanowski M, Ehmann F, Dossena S, Paulmichl M,. Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective. Nat Rev Drug Discov 2013; 12: 103-115. doi: 10.1038/nrd3931.
-
(2013)
Nat Rev Drug Discov
, vol.12
, pp. 103-115
-
-
Maliepaard, M.1
Nofziger, C.2
Papaluca, M.3
Zineh, I.4
Uyama, Y.5
Prasad, K.6
Grimstein, C.7
Pacanowski, M.8
Ehmann, F.9
Dossena, S.10
Paulmichl, M.11
-
6
-
-
0008348082
-
-
European Medicines Agency (EMA) Available at (last accessed 7 December 2013)
-
European Medicines Agency (EMA). European public assessment reports. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/ landing/epar-search.jsp&mid=WC0b01ac058001d124 (last accessed 7 December 2013).
-
European Public Assessment Reports
-
-
-
7
-
-
84897858221
-
-
Available at (last accessed 7 December 2013)
-
EMA product information: Xaluprine, mercaptopurine. Available at http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/002022/WC500124645.pdf (last accessed 7 December 2013).
-
EMA Product Information: Xaluprine, Mercaptopurine
-
-
-
8
-
-
84897859374
-
-
Available at (last accessed 7 December 2013)
-
EMA product information: clopidogrel Apotex, clopidogrel. Available at http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/001189/WC500029701.pdf (last accessed 7 December 2013).
-
EMA Product Information: Clopidogrel Apotex, Clopidogrel
-
-
-
9
-
-
84897874716
-
-
Available at (last accessed 7 December 2013)
-
EMA product information: Ziagen, abacavir. Available at http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000252/WC500050343.pdf (last accessed 7 December 2013).
-
EMA Product Information: Ziagen, Abacavir
-
-
-
10
-
-
84897832040
-
-
Available at (last accessed 7 December 2013)
-
Innovation task force (ITF) at the European medicines agency (EMA). Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/ general/general-content-000334.jsp&mid=WC0b01ac05800ba1d9 (last accessed 7 December 2013).
-
Innovation Task Force (ITF) at the European Medicines Agency (EMA)
-
-
-
11
-
-
84897868299
-
-
Available at (last accessed 7 December 2013)
-
Emerging science at the EMA. Available at http://www.ema.europa.eu/ema/ index.jsp?curl=pages/special-topics/general/general-content-000339.jsp&mid= WC0b01ac05800baed8 (last accessed 7 December 2013).
-
Emerging Science at the EMA
-
-
-
12
-
-
84876690294
-
Gatekeepers and enablers: How drug regulators Respond to a challenging and changing environment by moving toward a proactive attitude
-
doi: 10.1038/clpt.2013.14
-
Ehmann F, Papaluca Amati M, Salmonson T, Posch M, Vamvakas S, Hemmings R, Eichler HG, Schneider CK,. Gatekeepers and enablers: how drug regulators Respond to a challenging and changing environment by moving toward a proactive attitude. Clin Pharmacol Ther 2013; 93: 425-432. doi: 10.1038/clpt.2013.14.
-
(2013)
Clin Pharmacol Ther
, vol.93
, pp. 425-432
-
-
Ehmann, F.1
Papaluca Amati, M.2
Salmonson, T.3
Posch, M.4
Vamvakas, S.5
Hemmings, R.6
Eichler, H.G.7
Schneider, C.K.8
-
13
-
-
84897908351
-
-
Available at (last accessed 7 December 2013)
-
EMA scientific advice procedure. Available at http://www.ema.europa.eu/ ema/index.jsp?curl=pages/regulation/general/general-content-000049.jsp&mid= WC0b01ac05800229b9 (last accessed 7 December 2013).
-
EMA Scientific Advice Procedure
-
-
-
14
-
-
84897873028
-
-
Available at (last accessed 7 December 2013)
-
EMA qualification of novel methodologies for medicine development. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/ document-listing/document-listing-000319.jsp&mid=WC0b01ac0580022bb0 (last accessed 7 December 2013).
-
EMA Qualification of Novel Methodologies for Medicine Development
-
-
-
15
-
-
84865853084
-
Personalized medicine: Is it a pharmacogenetic mirage?
-
Shah RR, Shah DR,. Personalized medicine: is it a pharmacogenetic mirage? Br J Clin Pharmacol 2012; 74: 698-721.
-
(2012)
Br J Clin Pharmacol
, vol.74
, pp. 698-721
-
-
Shah, R.R.1
Shah, D.R.2
-
16
-
-
84879671097
-
-
July - Issue number: 1207. Available at (last accessed 7 December 2013)
-
PhVWP monthly report on safety concerns, guidelines and general matters. July 2012-Issue number: 1207. Available at http://www.ema.europa.eu/docs/en-GB/ document-library/Report/2012/07/WC500130391.pdf (last accessed 7 December 2013).
-
(2012)
PhVWP Monthly Report on Safety Concerns, Guidelines and General Matters
-
-
-
17
-
-
84897824794
-
-
Available at (last accessed 7 December 2013)
-
Joint EMA scientific advice with HTA bodies. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners-and-networks/general/ general-content-000476.jsp&mid=WC0b01ac0580236a57 (last accessed 7 December 2013).
-
Joint EMA Scientific Advice with HTA Bodies
-
-
-
19
-
-
84877278637
-
Implementing personalized cancer genomics in clinical trials
-
doi: 10.1038/nrd3979
-
Simon R, Roychowdhury S,. Implementing personalized cancer genomics in clinical trials. Nat Rev Drug Discov 2013; 12: 358-369. doi: 10.1038/nrd3979.
-
(2013)
Nat Rev Drug Discov
, vol.12
, pp. 358-369
-
-
Simon, R.1
Roychowdhury, S.2
-
20
-
-
84885021119
-
Considerations for the successful co-development of targeted cancer therapies and companion diagnostics
-
doi: 10.1038/nrd4101
-
Fridlyand J, Simon RM, Walrath JC, Roach N, Buller R, Schenkein DP, Flaherty KT, Allen JD, Sigal EV, Scher HI,. Considerations for the successful co-development of targeted cancer therapies and companion diagnostics. Nat Rev Drug Discov 2013; 12: 743-755. doi: 10.1038/nrd4101.
-
(2013)
Nat Rev Drug Discov
, vol.12
, pp. 743-755
-
-
Fridlyand, J.1
Simon, R.M.2
Walrath, J.C.3
Roach, N.4
Buller, R.5
Schenkein, D.P.6
Flaherty, K.T.7
Allen, J.D.8
Sigal, E.V.9
Scher, H.I.10
-
21
-
-
84897850467
-
-
Available at (last accessed 7 December 2013)
-
European public assessment report (EPAR) for herceptin (trastuzumab). Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/000278/human-med-000818.jsp&mid=WC0b01ac058001d124 (last accessed 7 December 2013).
-
European Public Assessment Report (EPAR) for Herceptin (Trastuzumab)
-
-
-
23
-
-
84882644323
-
Implications of genome-wide association studies in cancer therapeutics
-
Patel JN, McLeod HL, Innocenti F,. Implications of genome-wide association studies in cancer therapeutics. Br J Clin Pharmacol 2013; 76: 370-380.
-
(2013)
Br J Clin Pharmacol
, vol.76
, pp. 370-380
-
-
Patel, J.N.1
McLeod, H.L.2
Innocenti, F.3
-
24
-
-
85027935630
-
Pharmacogenetic testing: Time for clinical practice guidelines
-
doi: 10.1038/clpt.2011.18
-
Amstutz U, Carleton BC,. Pharmacogenetic testing: time for clinical practice guidelines. Clin Pharmacol Ther 2011; 89: 924-927. doi: 10.1038/clpt.2011.18.
-
(2011)
Clin Pharmacol Ther
, vol.89
, pp. 924-927
-
-
Amstutz, U.1
Carleton, B.C.2
-
25
-
-
84897824881
-
-
European Commission DG Justice Available at (last accessed 7 December 2013)
-
European Commission DG Justice. European Commission justice data protection legislation. Available at http://ec.europa.eu/justice/data- protection/law/index-en.htm (last accessed 7 December 2013).
-
European Commission Justice Data Protection Legislation
-
-
|