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Mitra Azadeh

Explore the profile of Mitra Azadeh including associated specialties, affiliations and a list of published articles. Areas
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Articles 15
Citations 80
Followers 0
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Recent Articles
1.
Jani D, Gunsior M, Marsden R, Cowan K, Irvin S, Hay L, et al.
AAPS J . 2024 Sep; 26(5):98. PMID: 39231893
No abstract available.
2.
Azadeh M, Good J, Gunsior M, Kulagina N, Lu Y, McNally J, et al.
AAPS J . 2024 Aug; 26(5):97. PMID: 39179710
Aberrant or dysfunctional cellular enzymes are responsible for a wide range of diseases including cancer, neurodegenerative conditions, and metabolic disorders. Deficiencies in enzyme level or biofunction may lead to intracellular...
3.
Jani D, Gunsior M, Marsden R, Cowan K, Irvin S, Hay L, et al.
AAPS J . 2024 Jul; 26(4):80. PMID: 38992280
Immunogenicity testing and characterization is an important part of understanding the immune response to administration of a protein therapeutic. Neutralizing antibody (NAb) assays are used to characterize a positive anti-drug...
4.
Baratta M, Jian W, Hengel S, Kaur S, Cunliffe J, Boer J, et al.
Bioanalysis . 2024 Jun; 16(9):307-364. PMID: 38913185
The 17 Workshop on Recent Issues in Bioanalysis (17 WRIB) took place in Orlando, FL, USA on June 19-23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory...
5.
Kholmanskikh O, Wang Y, Hersey S, Wadhwa M, Block K, Bandukwala A, et al.
Bioanalysis . 2024 Jun; 16(8):179-220. PMID: 38899739
The 17 Workshop on Recent Issues in Bioanalysis (17 WRIB) took place in Orlando, FL, USA on 19-23 June 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory...
6.
Hays A, Wissel M, Colletti K, Soon R, Azadeh M, Smith J, et al.
AAPS J . 2024 Feb; 26(1):24. PMID: 38316745
The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions on lack of harmonization on...
7.
Eitan E, Thornton-Wells T, Elgart K, Erden E, Gershun E, Levine A, et al.
Extracell Vesicles Circ Nucl Acids . 2023 Oct; 4(1):133-150. PMID: 37842184
Aims: Blood biomarkers can improve drug development for Alzheimer's disease (AD) and its treatment. Neuron-derived extracellular vesicles (NDEVs) in plasma offer a minimally invasive platform for developing novel biomarkers that...
8.
Sumner G, Keller S, Huleatt J, Staack R, Wagner L, Azadeh M, et al.
Bioanalysis . 2023 Aug; 15(15):861-903. PMID: 37584363
The 16 Workshop on Recent Issues in Bioanalysis (16 WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory...
9.
Gorovits B, Azadeh M, Buchlis G, Fiscella M, Harrison T, Havert M, et al.
AAPS J . 2023 Apr; 25(3):47. PMID: 37101079
The number of approved or investigational late phase viral vector gene therapies (GTx) has been rapidly growing. The adeno-associated virus vector (AAV) technology continues to be the most used GTx...
10.
Jani D, Marsden R, Gunsior M, Hay L, Ward B, Cowan K, et al.
AAPS J . 2022 Oct; 24(6):113. PMID: 36307592
A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these...