Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals.

Autor: Park K; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Virparia R; University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA., Green DJ; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA., Epps C; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA., Wharton GT; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA., McCune SK; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA., Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Oct; Vol. 110 (4), pp. 997-1003. Date of Electronic Publication: 2021 Jun 14.

Appropriateness of thrombophilia testing in patients in the acute care setting and an evaluation of the associated costs.

Autor: Virparia R; Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, USA. riddhivirparia@gmail.com., Brunetti L; Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, USA.; Robert Wood Johnson University Hospital Somerset, RWJBarnabas Health, Somerville, NJ, USA., Vigdor S; Robert Wood Johnson University Hospital Somerset, RWJBarnabas Health, Somerville, NJ, USA., Adams CD; Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, USA.; Robert Wood Johnson University Hospital Somerset, RWJBarnabas Health, Somerville, NJ, USA.

Publikováno v: Journal of thrombosis and thrombolysis [J Thromb Thrombolysis] 2020 Jan; Vol. 49 (1), pp. 108-112.

Structured content and data management—enhancing acceleration in drug development through efficiency in data exchange.

Autor: Beierle, Jill¹ (AUTHOR) naclhoh@gmail.com, Algorri, Marquerita¹ (AUTHOR), Cortés, Marisol² (AUTHOR), Cauchon, Nina S.¹ (AUTHOR), Lennard, Andrew¹ (AUTHOR), Kirwan, J. Paul¹ (AUTHOR), Oghamian, Shirley¹ (AUTHOR), Abernathy, Michael J.¹ (AUTHOR)

Publikováno v: AAPS Open. 5/8/2023, Vol. 9 Issue 1, p1-19. 19p.

Thrombophilia Impact on Treatment Decisions, Subsequent Venous or Arterial Thrombosis and Pregnancy-Related Morbidity: A Retrospective Single-Center Cohort Study.

Autor: Vrotniakaite-Bajerciene, Kristina^1,2 (AUTHOR) katarzynaaleksandra.jalowiec@insel.ch, Tritschler, Tobias³ (AUTHOR) tobias.tritschler@insel.ch, Jalowiec, Katarzyna Aleksandra¹ (AUTHOR) helen.broughton@students.unibe.ch, Broughton, Helen^1,2 (AUTHOR) justine.brodard@insel.ch, Brodard, Justine^1,2 (AUTHOR) naomiazur.porret@insel.ch, Porret, Naomi Azur^1,2 (AUTHOR) alicia.rovo@insel.ch, Haynes, Alan⁴ (AUTHOR) alan.haynes@ctu.unibe.ch, Rovo, Alicia^1,2 (AUTHOR) johanna.kremer@insel.ch, Kremer Hovinga, Johanna Anna^1,2 (AUTHOR) anne.angelillo-scherrer@insel.ch, Aujesky, Drahomir³ (AUTHOR) drahomirantonin.aujesky@insel.ch, Angelillo-Scherrer, Anne^1,2 (AUTHOR)

Publikováno v: Journal of Clinical Medicine. Jul2022, Vol. 11 Issue 14, p4188-4188. 14p.

Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals.

Autor: Mooghali, Maryam, Mohammad, Ayman, Wallach, Joshua D., Mitchell, Aaron P., Ross, Joseph S., Ramachandran, Reshma

Publikováno v: JAMA Network Open; 5/1/2024, Vol. 7 Issue 4, pe249233-e249233, 1p