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Delayed-Release Dimethyl Fumarate and Pregnancy: Preclinical Studies and Pregnancy Outcomes from Clinical Trials and Postmarketing Experience.

Autor: Gold, Ralf, Phillips, J., Havrdova, Eva, Bar-Or, Amit, Kappos, Ludwig, Kim, Norman, Thullen, Tim, Valencia, Patricia, Oliva, Lauren, Novas, Mark, Li, Jie, Sweetser, Marianne, Kurukulasuriya, Nuwan, Viglietta, Vissia, Fox, Robert

Publikováno v: Neurology & Therapy; Dec2015, Vol. 4 Issue 2, p93-104, 12p

Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.

Autor: Stephenson D; Critical Path Institute, Tucson, Arizona, USA., Alexander R; Takeda, Cambridge, Massachusetts, USA., Aggarwal V; Critical Path Institute, Tucson, Arizona, USA., Badawy R; University of Birmingham, Birmingham, United Kingdom., Bain L; Independent Medical Writer, Philadelphia, Pennsylvania, USA., Bhatnagar R; Critical Path Institute, Tucson, Arizona, USA., Bloem BR; Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, The Netherlands., Boroojerdi B; UCB Biopharma, Brussels, Belgium., Burton J; Critical Path Institute, Tucson, Arizona, USA., Cedarbaum JM; Critical Path Institute, Tucson, Arizona, USA.; Coeruleus Clinical Sciences LLC, Woodbridge, Connecticut, USA., Cosman J; Biogen, Cambridge, Massachusetts, USA.; AbbVie, Chicago, Illinois, USA., Dexter DT; Parkinson's UK, London, United Kingdom., Dockendorf M; Merck & Co. (MSD), Kenilworth, New Jersey, USA., Dorsey ER; University of Rochester, Rochester, New York, USA., Dowling AV; Takeda, Cambridge, Massachusetts, USA., Evers LJW; Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, The Netherlands., Fisher K; Biogen, Cambridge, Massachusetts, USA., Frasier M; Michael J. Fox Foundation, New York, New York, USA., Garcia-Gancedo L; GlaxoSmithKline, Stevenage, United Kingdom., Goldsack JC; Digital Medicine Society, Boston, Massachusetts, USA., Hill D; Critical Path Institute, Tucson, Arizona, USA., Hitchcock J; Critical Path Institute, Tucson, Arizona, USA., Hu MT; Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom., Lawton MP; Critical Path Institute, Tucson, Arizona, USA., Lee SJ; Merck & Co. (MSD), Kenilworth, New Jersey, USA., Lindemann M; F. Hoffmann-La Roche Ltd., Basel, Switzerland., Marek K; Institute of Neurodegenerative Diseases, New Haven, Connecticut, USA., Mehrotra N; Merck & Co. (MSD), Kenilworth, New Jersey, USA., Meinders MJ; Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, The Netherlands., Minchik M; Critical Path Institute, Tucson, Arizona, USA., Oliva L; Biogen, Cambridge, Massachusetts, USA., Romero K; Critical Path Institute, Tucson, Arizona, USA., Roussos G; Critical Path Institute, Tucson, Arizona, USA.; Birbeck College, University of London, London, United Kingdom., Rubens R; Takeda, Cambridge, Massachusetts, USA., Sadar S; Critical Path Institute, Tucson, Arizona, USA., Scheeren J; Critical Path Institute, Tucson, Arizona, USA., Sengoku E; UCB Biopharma, Brussels, Belgium., Simuni T; Northwestern University, Evanston, Illinois, USA., Stebbins G; Rush University, Chicago, Illinois, USA., Taylor KI; F. Hoffmann-La Roche Ltd., Basel, Switzerland.; University of Basel, Basel, Switzerland., Yang B; Lundbeck, Copenhagen, Denmark., Zach N; Takeda, Cambridge, Massachusetts, USA.

Publikováno v: Digital biomarkers [Digit Biomark] 2020 Nov 26; Vol. 4 (Suppl 1), pp. 28-49. Date of Electronic Publication: 2020 Nov 26 (Print Publication: 2020).