European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products
Date:
04/12/2014 to 05/12/2014
Location:
European Medicines Agency, London, UK
EMA/EFPIA workshop is planned for 4-5 December 2014 to discuss the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products.Registration: please register by 19 September 2014 using the registration form provided.
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Report from the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and life... (PDF/188.76 KB)
First published: 17/04/2015
Last updated: 17/04/2015
EMA/117491/2015 -
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Agenda - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on the importance of dose finding and dose selection for the successful development, licensing and lif... (PDF/112.18 KB)
First published: 23/06/2014
Last updated: 07/01/2015
EMA/341714/2014 -
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Presentation - Workshop opening (Rob Hemmings, Efthymios Manolis) (PDF/733.47 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Dose selection in drug development and regulation: possible future direction (Richard Lalonde, Donald Stanski) (PDF/2.33 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Dose response assessments: guidance, experience, expectations (Vikram Sinha) (PDF/498.52 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby) (PDF/264.63 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Sarm I/Tadalafil pgase II combination study for erectile dysfunction: modeling and simulation to optimize study design (Charles Benson) (PDF/820.12 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Regulatory comments: pharmacometric principles in dose finding (Terry Shepard, Sofia Friberg Hietala) (PDF/389.13 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - An adaptive dose-finding study in postoperative dental pain. MCP-Mod (Bjà¶rn Bornkamp) (PDF/699.81 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Averaged model based decision making for dose selection studies (Yasunori Aoki, Bengt Hamrà©n, Daniel Rà¶shammar, Andrew C. Hooker) (PDF/39.95 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Model based dose finding: discussion of presentations given by Bjà¶rn Bornkamp and Andrew Hooker (Norbert Benda) (PDF/122.52 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Meta-analyses of clinical dose response (N. Thomas, D. Roy, V. Somayaji, K. Sweeney) (PDF/163.9 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Ph 2/3 trial for selepressin in the treatment of vasopressor-dependent septic shock (Scott Berry) (PDF/7.2 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Ph 2/3 trial for selepressin (Martin Posch) (PDF/209.32 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Session 2 summary: designs and methods (Jose Pinheiro) (PDF/75.35 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Dosing: examples from antipsychotics (Luca Pani) (PDF/24.32 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Ph2a dose selection based on the relationship between PK and target occupancy (Mona Alameddine, Patricia Sanwald Ducray) (PDF/349.87 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - A systems pharmacology perspective on the clinical development of fatty acid amide hydrolase inhibitors for pain (Piet van der Graaf) (PDF/1.46 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Dose finding for a β-lactam – β-lactamase inhibitor combination (Shampa Das, Astra Zeneca) (PDF/310.63 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Mechanism-based PKPD-models for selection of dosing regimens for antibiotics (Lena Friberg, Anders Kristoffersson, Elisabet Nielsen) (PDF/1.48 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - General principles of antiviral dose selection (Filip Josephson) (PDF/338.57 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Cabozantinib (Cometriq) (Frans Opdam) (PDF/260.92 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Shifting the MTD paradigm in oncology (Kevin Smart, Georgina Meneses-Lorente) (PDF/915.75 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - An oncology systems pharmacology approach to dose selection (James Yates) (PDF/499.87 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Agonists with different levels of affinity (Peter Mol) (PDF/178.78 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Dose-finding in the cardiovascular therapeutic area: the novel oral anticoagulants (Antonio Gà³mez-Outes) (PDF/1.26 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Key learnings from otamixaban development (Christophe Gaudin) (PDF/1.61 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Dose - response - anticoagulants (Robert Temple) (PDF/246.49 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Use of dose-exposure-response model in immunology/transplantation: general considerations and case study (T Dumortier, M Looby, Y Wang) (PDF/515.18 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Regulatory and physician view (Lisbeth Barkholt) (PDF/155.42 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Regulatory view (Flora Musuamba Tshinanu) (PDF/104.95 KB)
First published: 13/03/2015
Last updated: 13/03/2015 -
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Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - children (Dirk Mentzer, Ine Rusten) (PDF/269.25 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - Children (Anne Brochot) (PDF/183.33 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - D-E-R characterisation in dose selection, labelling and B/R assessment: focus on the elderly (Terry Shepard, Sue Morgan) (PDF/334.41 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Sub population: the elderly - How can modelling and simulation inform understanding of safety and efficacy? (Amy S. Y. Cheung) (PDF/265.21 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Dose and schedule determination and amendments of EU centrally approved products (CAPs) (Falk Ehmann) (PDF/430.41 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Impact of D-E-R information on regulatory approval and post-authorisation commitments: FDA perspective (Yaning Wang, Vikram Sinha) (PDF/316.77 KB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Regulatory evaluation and perspectives on dose-exposure-response information in new drug applications (Naoyuki Yabana, Naomi Nagai) (PDF/1.42 MB)
First published: 07/01/2015
Last updated: 07/01/2015 -
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Presentation - Dose selection in drug development and regulation: possible future direction concluding industry thinking (Richard Lalonde, Donald Stanski) (PDF/41.12 KB)
First published: 07/01/2015
Last updated: 07/01/2015