COMMUNICATION
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doi:10.20944/preprints202402.1423.v1
Subject:
Medicine And Pharmacology,
Oncology And Oncogenics
Keywords:
HER2+ breast cancer, monoclonal antibodies, trastuzumab biosimilars.
Online: 26 February 2024 (10:20:30 CET)
REVIEW
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doi:10.20944/preprints202309.0353.v1
Subject:
Medicine And Pharmacology,
Pharmacology And Toxicology
Keywords:
FDA; Omics technology; Pharmacodynamic biomarkers; biosimilars; Proteomics; Gycomis; Re-ceptor Binding; Pharmacokinetics
Online: 6 September 2023 (03:32:11 CEST)
ARTICLE
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doi:10.20944/preprints202308.2094.v1
Subject:
Medicine And Pharmacology,
Gastroenterology And Hepatology
Keywords:
biosimilars; bio-originators; biologic drug; ulcerative colitis; Crohn’s disease; interchangeability; economics
Online: 31 August 2023 (02:41:46 CEST)
REVIEW
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doi:10.20944/preprints202306.0380.v1
Subject:
Public Health And Healthcare,
Health Policy And Services
Keywords:
Biosimilars 1; Arab states 1; regulatory guideline 3; harmonization 4; centralized approval 5; EMA 6; FDA 7; Global Medicine Authority (GMA) 8.
Online: 6 June 2023 (08:49:00 CEST)
REVIEW
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doi:10.20944/preprints202304.1141.v1
Subject:
Medicine And Pharmacology,
Pharmacology And Toxicology
Keywords:
biosimilarity; biosimilars; pharmacodynamic biomarkers; monoclonal antibodies; FDA; clinical efficacy testing in healthy subjects; clinical efficacy testing in patients; functional assays; receptor binding
Online: 28 April 2023 (08:03:20 CEST)
REVIEW
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doi:10.20944/preprints202210.0397.v1
Subject:
Public Health And Healthcare,
Health Policy And Services
Keywords:
biosimilars; regulatory process; animal studies; clinical efficacy testing; interchangeability; FDA; EMA; MHRA; MENA; cGMP
Online: 26 October 2022 (03:58:16 CEST)