Amitava Mitra
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Explore the profile of Amitava Mitra including associated specialties, affiliations and a list of published articles.
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68
Citations
816
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Recent Articles
1.
Mitra A, Ahsan J, Tabachri M, El-Shahat T, Leoni M, Dale S
Clin Transl Sci
. 2025 Feb;
18(2):e70153.
PMID: 39928533
Ziftomenib, a potent, selective inhibitor that binds menin at the lysine methyltransferase 2 interaction site, has demonstrated promising clinical activity with manageable toxicity in heavily pretreated patients with acute myeloid...
2.
Tannergren C, Arora S, Babiskin A, Borges L, Chatterjee P, Cheng Y, et al.
Mol Pharm
. 2024 Dec;
22(1):5-27.
PMID: 39680866
This report summarizes the proceedings for Day 3 of the workshop titled "". This day focused on the current and future drug product quality applications of PBBM from the innovator...
3.
Wang E, Issa G, Erba H, Altman J, Montesinos P, DeBotton S, et al.
Lancet Oncol
. 2024 Oct;
25(10):1310-1324.
PMID: 39362248
Background: Ziftomenib (KO-539) is an oral selective menin inhibitor with known preclinical activity in menin-dependent acute myeloid leukaemia models. The primary objective of this study was to determine the recommended...
4.
Heimbach T, Musuamba Tshinanu F, Raines K, Borges L, Kijima S, Malamatari M, et al.
Mol Pharm
. 2024 Sep;
21(11):5353-5372.
PMID: 39348508
The proceedings from the 30th August 2023 (Day 2) of the workshop "Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives" are provided herein....
5.
Ahmed M, Krishna R, Rayad N, Albusaysi S, Mitra A, Shang E, et al.
Clin Pharmacol Ther
. 2024 Aug;
116(6):1412-1432.
PMID: 39148459
In the relentless pursuit of optimizing drug development, the intricate process of determining the ideal dosage unfolds. This involves "dose-finding" studies, crucial for providing insights into subsequent registration trials. However,...
6.
Mitra A, Tania N, Ahmed M, Rayad N, Krishna R, Albusaysi S, et al.
Clin Pharmacol Ther
. 2024 Jul;
116(6):1398-1411.
PMID: 38989644
Model-informed approaches provide a quantitative framework to integrate all available nonclinical and clinical data, thus furnishing a totality of evidence approach to drug development and regulatory evaluation. Maximizing the use...
7.
Pepin X, Arora S, Borges L, Cano-Vega M, Carducci T, Chatterjee P, et al.
Mol Pharm
. 2024 Jul;
21(8):3697-3731.
PMID: 38946085
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". The focus...
8.
Okudaira N, Burt H, Mitra A
CPT Pharmacometrics Syst Pharmacol
. 2024 May;
13(8):1366-1379.
PMID: 38807307
A physiologically-based pharmacokinetic (PBPK) model for tipifarnib, which included mechanistic absorption, was built and verified by integrating in vitro data and several clinical data in healthy subjects and cancer patients....
9.
Mackie C, Arora S, Seo P, Moody R, Rege B, Pepin X, et al.
Mol Pharm
. 2024 Apr;
21(5):2065-2080.
PMID: 38600804
Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models...
10.
Soylu I, Lakshman D, Tatineni S, Galvez L, Mitra A
BMC Genomics
. 2024 Feb;
25(1):221.
PMID: 38418960
Background: Wheat streak mosaic virus (WSMV) and Triticum mosaic virus (TriMV) are components of the wheat streak mosaic virus disease complex in the Great Plains region of the U.S.A. and...