Date
Location
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.
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...
English (EN) (188.76 KB - PDF)
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...
English (EN) (112.18 KB - PDF)
Presentation - Workshop opening (Rob Hemmings, Efthymios Manolis)
English (EN) (733.47 KB - PDF)
Presentation - Dose selection in drug development and regulation: possible future direction (Richard Lalonde, Donald Stanski)
English (EN) (2.33 MB - PDF)
Presentation - Dose response assessments: guidance, experience, expectations (Vikram Sinha)
English (EN) (498.52 KB - PDF)
Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby)
English (EN) (264.63 KB - PDF)
Presentation - Sarm I/Tadalafil pgase II combination study for erectile dysfunction: modeling and simulation to optimize study design (Charles Benson)
English (EN) (820.12 KB - PDF)
Presentation - Regulatory comments: pharmacometric principles in dose finding (Terry Shepard, Sofia Friberg Hietala)
English (EN) (389.13 KB - PDF)
Presentation - An adaptive dose-finding study in postoperative dental pain. MCP-Mod (Bjà¶rn Bornkamp)
English (EN) (699.81 KB - PDF)
Presentation - Averaged model based decision making for dose selection studies (Yasunori Aoki, Bengt Hamrà©n, Daniel Rà¶shammar, Andrew C. Hooker)
English (EN) (39.95 MB - PDF)
Presentation - Model based dose finding: discussion of presentations given by Bjà¶rn Bornkamp and Andrew Hooker (Norbert Benda)
English (EN) (122.52 KB - PDF)
Presentation - Meta-analyses of clinical dose response (N. Thomas, D. Roy, V. Somayaji, K. Sweeney)
English (EN) (163.9 KB - PDF)
Presentation - Ph 2/3 trial for selepressin in the treatment of vasopressor-dependent septic shock (Scott Berry)
English (EN) (7.2 MB - PDF)
Presentation - Ph 2/3 trial for selepressin (Martin Posch)
English (EN) (209.32 KB - PDF)
Presentation - Session 2 summary: designs and methods (Jose Pinheiro)
English (EN) (75.35 KB - PDF)
Presentation - Dosing: examples from antipsychotics (Luca Pani)
English (EN) (24.32 MB - PDF)
Presentation - Ph2a dose selection based on the relationship between PK and target occupancy (Mona Alameddine, Patricia Sanwald Ducray)
English (EN) (349.87 KB - PDF)
Presentation - A systems pharmacology perspective on the clinical development of fatty acid amide hydrolase inhibitors for pain (Piet van der Graaf)
English (EN) (1.46 MB - PDF)
Presentation - Dose finding for a β-lactam – β-lactamase inhibitor combination (Shampa Das, Astra Zeneca)
English (EN) (310.63 KB - PDF)
Presentation - Mechanism-based PKPD-models for selection of dosing regimens for antibiotics (Lena Friberg, Anders Kristoffersson, Elisabet Nielsen)
English (EN) (1.48 MB - PDF)
Presentation - General principles of antiviral dose selection (Filip Josephson)
English (EN) (338.57 KB - PDF)
Presentation - Cabozantinib (Cometriq) (Frans Opdam)
English (EN) (260.92 KB - PDF)
Presentation - Shifting the MTD paradigm in oncology (Kevin Smart, Georgina Meneses-Lorente)
English (EN) (915.75 KB - PDF)
Presentation - An oncology systems pharmacology approach to dose selection (James Yates)
English (EN) (499.87 KB - PDF)
Presentation - Agonists with different levels of affinity (Peter Mol)
English (EN) (178.78 KB - PDF)
Presentation - Dose-finding in the cardiovascular therapeutic area: the novel oral anticoagulants (Antonio Gà³mez-Outes)
English (EN) (1.26 MB - PDF)
Presentation - Key learnings from otamixaban development (Christophe Gaudin)
English (EN) (1.61 MB - PDF)
Presentation - Dose - response - anticoagulants (Robert Temple)
English (EN) (246.49 KB - PDF)
Presentation - Use of dose-exposure-response model in immunology/transplantation: general considerations and case study (T Dumortier, M Looby, Y Wang)
English (EN) (515.18 KB - PDF)
Presentation - Regulatory and physician view (Lisbeth Barkholt)
English (EN) (155.42 KB - PDF)
Presentation - Regulatory view (Flora Musuamba Tshinanu)
English (EN) (104.95 KB - PDF)
Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - children (Dirk Mentzer, Ine Rusten)
English (EN) (269.25 KB - PDF)
Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - Children (Anne Brochot)
English (EN) (183.33 KB - PDF)
Presentation - D-E-R characterisation in dose selection, labelling and B/R assessment: focus on the elderly (Terry Shepard, Sue Morgan)
English (EN) (334.41 KB - PDF)
Presentation - Sub population: the elderly - How can modelling and simulation inform understanding of safety and efficacy? (Amy S. Y. Cheung)
English (EN) (265.21 KB - PDF)
Presentation - Dose and schedule determination and amendments of EU centrally approved products (CAPs) (Falk Ehmann)
English (EN) (430.41 KB - PDF)
Presentation - Impact of D-E-R information on regulatory approval and post-authorisation commitments: FDA perspective (Yaning Wang, Vikram Sinha)
English (EN) (316.77 KB - PDF)
Presentation - Regulatory evaluation and perspectives on dose-exposure-response information in new drug applications (Naoyuki Yabana, Naomi Nagai)
English (EN) (1.42 MB - PDF)
Presentation - Dose selection in drug development and regulation: possible future direction concluding industry thinking (Richard Lalonde, Donald Stanski)
English (EN) (41.12 KB - PDF)
A video recording is now available.
To view use the 'Multimedia' tab.