The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data.

Autor: Zou KH; Viatris, Canonsburg, PA, USA., Vigna C; Medidata Solutions, a Dassault Systèmes Company, Boston, MA, USA., Talwai A; Medidata Solutions, a Dassault Systèmes Company, Boston, MA, USA., Jain R; Medidata Solutions, a Dassault Systèmes Company, Boston, MA, USA., Galaznik A; Medidata Solutions, a Dassault Systèmes Company, Boston, MA, USA., Berger ML; Medidata Solutions, a Dassault Systèmes Company, Boston, MA, USA., Li JZ; Viatris, Canonsburg, PA, USA. Jim.Li@viatris.com.

Publikováno v: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 May; Vol. 58 (3), pp. 443-455. Date of Electronic Publication: 2024 Mar 25.

Real-World Data and Real-World Evidence in Healthcare in the United States and Europe Union.

Autor: Zou KH; Viatris Inc., Canonsburg, PA 15317, USA.; AI4Purpose Inc., New York, NY 10016, USA., Berger ML; Marc L. Berger, LLC., New York, NY 10026, USA.

Publikováno v: Bioengineering (Basel, Switzerland) [Bioengineering (Basel)] 2024 Aug 02; Vol. 11 (8). Date of Electronic Publication: 2024 Aug 02.

Alternative and legacy flame retardants in marine mammals from three northern ocean regions.

Autor: Berger ML; Shaw Institute, PO Box 1652, 55 Main Street, Blue Hill, ME, 04614, USA. Electronic address: mberger@shawinstitute.org., Shaw SD; Shaw Institute, PO Box 1652, 55 Main Street, Blue Hill, ME, 04614, USA., Rolsky CB; Shaw Institute, PO Box 1652, 55 Main Street, Blue Hill, ME, 04614, USA., Chen D; School of Environment and Guangdong Key Laboratory of Environmental Pollution and Health, Jinan University, Guangzhou, Guangdong, 510632, China; Cooperative Wildlife Research Laboratory and Department of Zoology, Southern Illinois University, Carbondale, IL, 62901, USA., Sun J; School of Environment and Guangdong Key Laboratory of Environmental Pollution and Health, Jinan University, Guangzhou, Guangdong, 510632, China; College of Marine Life Science, Ocean University of China, CN-266003, Qingdao, China., Rosing-Asvid A; Greenland Climate Research Centre, Greenland Institute of Natural Resources, Kivioq 2, PO Box 570, 3900, Nuuk, Greenland., Granquist SM; Seal Research Department, The Icelandic Seal Center, Höfðabraut 6, 530 Hvammstangi, Iceland; Marine and Freshwater Research Institute, Fornubúðir 5, 220 Hafnarfjörður, Iceland., Simon M; Greenland Climate Research Centre, Greenland Institute of Natural Resources, Kivioq 2, PO Box 570, 3900, Nuuk, Greenland., Bäcklin BM; Department of Environmental Research and Monitoring, Swedish Museum of Natural History, PO Box 104 05 Stockholm, Sweden., Roos AM; Greenland Climate Research Centre, Greenland Institute of Natural Resources, Kivioq 2, PO Box 570, 3900, Nuuk, Greenland; Department of Environmental Research and Monitoring, Swedish Museum of Natural History, PO Box 104 05 Stockholm, Sweden.

Publikováno v: Environmental pollution (Barking, Essex : 1987) [Environ Pollut] 2023 Oct 15; Vol. 335, pp. 122255. Date of Electronic Publication: 2023 Jul 28.

Occurrence and tissue-specific partitioning of alternative brominated flame retardants in northwest Atlantic harbor seal pups (Phoca vitulina vitulina).

Autor: Berger ML; Shaw Institute, Blue Hill Research Center, 55 Main Street, Blue Hill, ME, 04614, USA. Electronic address: mberger@shawinstitute.org., Shaw SD; Shaw Institute, Blue Hill Research Center, 55 Main Street, Blue Hill, ME, 04614, USA., Rolsky C; Shaw Institute, Blue Hill Research Center, 55 Main Street, Blue Hill, ME, 04614, USA., Harris JH; Shaw Institute, Blue Hill Research Center, 55 Main Street, Blue Hill, ME, 04614, USA., Guo Y; School of Environment, Jinan University, Guangzhou, 510632, China., Kannan K; Department of Pediatrics and Department of Environmental Medicine, New York University School of Medicine, 550 First Avenue, 698 MSB 6th Floor, New York, NY, 10016, USA.

Publikováno v: Chemosphere [Chemosphere] 2023 Mar; Vol. 318, pp. 137968. Date of Electronic Publication: 2023 Jan 25.

HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force.

Autor: Wang SV; Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: swang1@bwh.harvard.edu., Pottegård A; University of Southern Denmark, Odense, Denmark., Crown W; Brandeis University, Waltham, Massachusetts, USA., Arlett P; European Medicines Agency, London, UK., Ashcroft DM; School of Health Sciences, University of Manchester, Manchester, UK., Benchimol EI; Child Health Evaluative Sciences, SickKids Research Institute, Toronto, Ontario, Canada; ICES, Toronto, Ontario, Canada; Department of Paediatrics and Institute of Health Policy, Management and Evaluation, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada., Berger ML; Independent Consultant, New York, USA., Crane G; Roche Pharmaceuticals, Camberley, UK., Goettsch W; The National Health Care Institute, Diemen, The Netherlands; Utrecht University, Utrecht, The Netherlands., Hua W; US Food and Drug Administration, Silver Springs, Maryland, USA., Kabadi S; Sanofi-Aventis US LLC, North Potomac, Maryland, USA., Kern DM; Janssen Research & Development, LLC, Philadelphia, Pennsylvania, USA., Kurz X; European Medicines Agency, London, UK., Langan S; London School of Tropical Hygiene, London, UK., Nonaka T; Pharmaceutical and Medical Devices Agency, Japan., Orsini L; COMPASS Pathways Ltd, Skillman, UK., Perez-Gutthann S; RTI Health Solutions, Barcelona, Spain., Pinheiro S; US Food and Drug Administration, Silver Springs, Maryland, USA., Pratt N; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, South Australia, Australia., Schneeweiss S; Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA., Toussi M; IQVIA, France., Williams RJ; Bethesda, Maryland, USA.

Publikováno v: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [Value Health] 2022 Oct; Vol. 25 (10), pp. 1663-1672.