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1.
Dispensing pharmacy chains and direct anticoagulants: Potential associations with patient outcomes.
Pharmacoepidemiol Drug Saf
; 33(2): e5749, 2024 Feb.
Article
in English
| MEDLINE | ID: mdl-38362655
2.
Early antibody responses associated with survival in COVID19 patients.
PLoS Pathog
; 17(7): e1009766, 2021 07.
Article
in English
| MEDLINE | ID: mdl-34280244
3.
Biosimilars: The US Regulatory Framework.
Annu Rev Med
; 68: 243-254, 2017 01 14.
Article
in English
| MEDLINE | ID: mdl-27813877
4.
Uptake and Competition Among Biosimilar Biological Products in the US Medicare Fee-for-Service Population.
J Gen Intern Med
; 37(16): 4292-4294, 2022 12.
Article
in English
| MEDLINE | ID: mdl-35650468
5.
A case of coronavirus disease 2019 messenger RNA vaccine tolerance and immune response despite presence of anti-polyethylene glycol antibodies.
Ann Allergy Asthma Immunol
; 129(2): 246-248, 2022 08.
Article
in English
| MEDLINE | ID: mdl-35605816
6.
Uptake and Usage Patterns of Biosimilar Infliximab in the Medicare Population.
J Gen Intern Med
; 36(7): 2170-2173, 2021 07.
Article
in English
| MEDLINE | ID: mdl-32578017
7.
A network of regulatory innovations to improve FDA quality assessments of human drug applications.
Int J Pharm X
; 7: 100239, 2024 Jun.
Article
in English
| MEDLINE | ID: mdl-38545329
8.
Uptake of the Biologic Filgrastim and Its Biosimilar Product Among the Medicare Population.
JAMA
; 320(9): 929-931, 2018 09 04.
Article
in English
| MEDLINE | ID: mdl-30193265
9.
Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination.
Vaccine
; 41(28): 4183-4189, 2023 06 23.
Article
in English
| MEDLINE | ID: mdl-37244808
10.
An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US.
Int J Pharm
; 622: 121778, 2022 Jun 25.
Article
in English
| MEDLINE | ID: mdl-35500688
11.
Outbreak of adverse reactions associated with contaminated heparin.
N Engl J Med
; 359(25): 2674-84, 2008 Dec 18.
Article
in English
| MEDLINE | ID: mdl-19052120
12.
A novel murine in vivo model for acute hereditary angioedema attacks.
Sci Rep
; 11(1): 15924, 2021 08 05.
Article
in English
| MEDLINE | ID: mdl-34354123
13.
Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008.
Pharmacoepidemiol Drug Saf
; 19(9): 921-33, 2010 Sep.
Article
in English
| MEDLINE | ID: mdl-20661880
14.
The FDA's assessment of follow-on protein products: a historical perspective.
Nat Rev Drug Discov
; 6(6): 437-42, 2007 06.
Article
in English
| MEDLINE | ID: mdl-17633790
15.
Developing the nation's biosimilars program.
N Engl J Med
; 365(5): 385-8, 2011 Aug 04.
Article
in English
| MEDLINE | ID: mdl-21812668
16.
Healthy User Bias in Comparative Safety Studies for Brand-Name vs. Generic Products: The Example of Warfarin.
Clin Pharmacol Ther
; 106(5): 1037-1045, 2019 11.
Article
in English
| MEDLINE | ID: mdl-31062343
17.
Biosimilar Uptake in Medicare Advantage vs Traditional Medicare.
JAMA Health Forum
; 4(12): e234335, 2023 Dec 01.
Article
in English
| MEDLINE | ID: mdl-38153810
18.
Current and future issues in the manufacturing and development of monoclonal antibodies.
Adv Drug Deliv Rev
; 58(5-6): 707-22, 2006 Aug 07.
Article
in English
| MEDLINE | ID: mdl-16828921
19.
Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.
Int J Pharm
; 515(1-2): 390-402, 2016 Dec 30.
Article
in English
| MEDLINE | ID: mdl-27773853
20.
Anti-PEG IgE in anaphylaxis associated with polyethylene glycol.
J Allergy Clin Immunol Pract
; 9(4): 1731-1733.e3, 2021 04.
Article
in English
| MEDLINE | ID: mdl-33217616