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

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.

Documents

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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 Î²-lactam – Î²-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

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

Documents

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)

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)

Presentation - Workshop opening (Rob Hemmings, Efthymios Manolis) (PDF/733.47 KB)

Presentation - Dose selection in drug development and regulation: possible future direction (Richard Lalonde, Donald Stanski) (PDF/2.33 MB)

Presentation - Dose response assessments: guidance, experience, expectations (Vikram Sinha) (PDF/498.52 KB)

Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby) (PDF/264.63 KB)

Presentation - Sarm I/Tadalafil pgase II combination study for erectile dysfunction: modeling and simulation to optimize study design (Charles Benson) (PDF/820.12 KB)

Presentation - Regulatory comments: pharmacometric principles in dose finding (Terry Shepard, Sofia Friberg Hietala) (PDF/389.13 KB)

Presentation - An adaptive dose-finding study in postoperative dental pain. MCP-Mod (Bjà¶rn Bornkamp) (PDF/699.81 KB)

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)

Presentation - Model based dose finding: discussion of presentations given by Bjà¶rn Bornkamp and Andrew Hooker (Norbert Benda) (PDF/122.52 KB)

Presentation - Meta-analyses of clinical dose response (N. Thomas, D. Roy, V. Somayaji, K. Sweeney) (PDF/163.9 KB)

Presentation - Ph 2/3 trial for selepressin in the treatment of vasopressor-dependent septic shock (Scott Berry) (PDF/7.2 MB)

Presentation - Ph 2/3 trial for selepressin (Martin Posch) (PDF/209.32 KB)

Presentation - Session 2 summary: designs and methods (Jose Pinheiro) (PDF/75.35 KB)

Presentation - Dosing: examples from antipsychotics (Luca Pani) (PDF/24.32 MB)

Presentation - Ph2a dose selection based on the relationship between PK and target occupancy (Mona Alameddine, Patricia Sanwald Ducray) (PDF/349.87 KB)

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)

Presentation - Dose finding for a Î²-lactam – Î²-lactamase inhibitor combination (Shampa Das, Astra Zeneca) (PDF/310.63 KB)

Presentation - Mechanism-based PKPD-models for selection of dosing regimens for antibiotics (Lena Friberg, Anders Kristoffersson, Elisabet Nielsen) (PDF/1.48 MB)

Presentation - General principles of antiviral dose selection (Filip Josephson) (PDF/338.57 KB)

Presentation - Cabozantinib (Cometriq) (Frans Opdam) (PDF/260.92 KB)

Presentation - Shifting the MTD paradigm in oncology (Kevin Smart, Georgina Meneses-Lorente) (PDF/915.75 KB)

Presentation - An oncology systems pharmacology approach to dose selection (James Yates) (PDF/499.87 KB)

Presentation - Agonists with different levels of affinity (Peter Mol) (PDF/178.78 KB)

Presentation - Dose-finding in the cardiovascular therapeutic area: the novel oral anticoagulants (Antonio Gà³mez-Outes) (PDF/1.26 MB)

Presentation - Key learnings from otamixaban development (Christophe Gaudin) (PDF/1.61 MB)

Presentation - Dose - response - anticoagulants (Robert Temple) (PDF/246.49 KB)

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)

Presentation - Regulatory and physician view (Lisbeth Barkholt) (PDF/155.42 KB)

Presentation - Regulatory view (Flora Musuamba Tshinanu) (PDF/104.95 KB)

Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - children (Dirk Mentzer, Ine Rusten) (PDF/269.25 KB)

Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - Children (Anne Brochot) (PDF/183.33 KB)

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)

Presentation - Sub population: the elderly - How can modelling and simulation inform understanding of safety and efficacy? (Amy S. Y. Cheung) (PDF/265.21 KB)

Presentation - Dose and schedule determination and amendments of EU centrally approved products (CAPs) (Falk Ehmann) (PDF/430.41 KB)

Presentation - Impact of D-E-R information on regulatory approval and post-authorisation commitments: FDA perspective (Yaning Wang, Vikram Sinha) (PDF/316.77 KB)

Presentation - Regulatory evaluation and perspectives on dose-exposure-response information in new drug applications (Naoyuki Yabana, Naomi Nagai) (PDF/1.42 MB)

Presentation - Dose selection in drug development and regulation: possible future direction concluding industry thinking (Richard Lalonde, Donald Stanski) (PDF/41.12 KB)

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