Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis
This thesis is submitted in partial fulfillment of the requirements for the degree of Bachelor of Pharmacy, 2021.
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Brac University
2022
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10361-170392022-07-25T21:01:37Z Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis Akter, Anika Alam, Marzia Department of Pharmacy, Brac University TNF-alpha Rheumatoid arthritis Biologics Biosimilars Adalimumab ABP-501 Pharmacokinetics Immunogenicity Plaque psoriasis Inflammation Immunity This thesis is submitted in partial fulfillment of the requirements for the degree of Bachelor of Pharmacy, 2021. Cataloged from PDF version of thesis report. Includes bibliographical references (pages 45-46). ABP-501 is a biosimilar of Adalimumab (Humira) and a tumor necrosis factor-alpha inhibitor that is responsible for inflammatory effects on the body. ABP-501 is equally effective against moderate to severe rheumatoid arthritis (RA) and plaque psoriasis (PsO). In this review, the pharmacokinetics, safety, efficacy, and immunogenicity data of ABP-501 were demonstrated. ABP-501 has been already approved by USFDA and EMA as a treatment option for RA and PsO. The phase-3 study pre-clinical and clinical data affirm ABP-501 was safe and effective against mild to moderate RA and PsO. ABP 501 is also reported for high similarity in structure, function, and pharmacodynamics (PD). This study also focuses on different regulatory issues with biologics and biosimilar such as their development, approval process, criteria that need to be met prior to approval. Anika Akter B. Pharmacy 2022-07-25T06:42:59Z 2022-07-25T06:42:59Z 2021 2021-12 Thesis ID 17346037 http://hdl.handle.net/10361/17039 en Brac University theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. 56 pages application/pdf Brac University |
institution |
Brac University |
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Institutional Repository |
language |
English |
topic |
TNF-alpha Rheumatoid arthritis Biologics Biosimilars Adalimumab ABP-501 Pharmacokinetics Immunogenicity Plaque psoriasis Inflammation Immunity |
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TNF-alpha Rheumatoid arthritis Biologics Biosimilars Adalimumab ABP-501 Pharmacokinetics Immunogenicity Plaque psoriasis Inflammation Immunity Akter, Anika Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis |
description |
This thesis is submitted in partial fulfillment of the requirements for the degree of Bachelor of Pharmacy, 2021. |
author2 |
Alam, Marzia |
author_facet |
Alam, Marzia Akter, Anika |
format |
Thesis |
author |
Akter, Anika |
author_sort |
Akter, Anika |
title |
Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis |
title_short |
Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis |
title_full |
Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis |
title_fullStr |
Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis |
title_full_unstemmed |
Pharmacokinetics, safety, efficacy and immunogenicity of Adalimumab biosimilar ABP-501in rheumatoid arthritis and plaque psoriasis |
title_sort |
pharmacokinetics, safety, efficacy and immunogenicity of adalimumab biosimilar abp-501in rheumatoid arthritis and plaque psoriasis |
publisher |
Brac University |
publishDate |
2022 |
url |
http://hdl.handle.net/10361/17039 |
work_keys_str_mv |
AT akteranika pharmacokineticssafetyefficacyandimmunogenicityofadalimumabbiosimilarabp501inrheumatoidarthritisandplaquepsoriasis |
_version_ |
1814308328602337280 |