Danuta Herzyk
Overview
Explore the profile of Danuta Herzyk including associated specialties, affiliations and a list of published articles.
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Articles
11
Citations
108
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Recent Articles
1.
Pallardy M, Bechara R, Whritenour J, Mitchell-Ryan S, Herzyk D, Lebrec H, et al.
Toxicol Sci
. 2024 Apr;
200(1):11-30.
PMID: 38588579
Drug hypersensitivity reactions (DHRs) are a type of adverse drug reaction that can occur with different classes of drugs and affect multiple organ systems and patient populations. DHRs can be...
2.
Prior H, Andrews L, Cauvin A, Chien H, Clarke D, Datta K, et al.
Regul Toxicol Pharmacol
. 2023 Jan;
138:105339.
PMID: 36649820
Assessment of reversibility from nonclinical toxicity findings in animals with potential adverse clinical impact is required during pharmaceutical development, but there is flexibility around how and when this is performed...
3.
Chien H, Prior H, Andrews L, van Aerts L, Cauvin A, Clarke D, et al.
Regul Toxicol Pharmacol
. 2023 Jan;
138:105329.
PMID: 36592682
To support registration of monoclonal antibodies (mAbs) for chronic indications, 6-month toxicity studies have historically been conducted. Experience with mAb development has shown a relatively benign and well-understood safety profile...
4.
Ackley D, Birkebak J, Blumel J, Bourcier T, de Zafra C, Goodwin A, et al.
Regul Toxicol Pharmacol
. 2022 Dec;
138:105327.
PMID: 36586472
The nonhuman primate (NHP) has always been a limited resource for pharmaceutical research with ongoing efforts to conserve. This is due to their inherent biological properties, the growth in biotherapeutics...
5.
MacLachlan T, Kronenberg S, Marshall N, Andrews L, Berens S, Brouta F, et al.
Regul Toxicol Pharmacol
. 2020 Nov;
119:104825.
PMID: 33220389
With the growth of monoclonal antibodies and other proteins as major modalities in the pharmaceutical industry, there has been an increase in pharmacology and toxicity testing of biotherapeutics in animals....
6.
Hutchins B, Starling G, McCoy M, Herzyk D, Poulet F, Dulos J, et al.
Mol Cancer Ther
. 2020 Apr;
19(6):1298-1307.
PMID: 32229606
The programmed cell death 1 (PD-1) pathway represents a major immune checkpoint, which may be engaged by cells in the tumor microenvironment to overcome active T-cell immune surveillance. Pembrolizumab (Keytruda®,...
7.
Santostefano M, Herzyk D, Montgomery D, Wolf J
Regul Toxicol Pharmacol
. 2019 Sep;
108:104476.
PMID: 31536773
Tildrakizumab (also known as MK-3222), is a high-affinity, humanized, immunoglobin G1κ monoclonal antibody targeting the p19 subunit of interleukin-23 recently approved for the treatment of moderate to severe plaque psoriasis...
8.
Guth B, Grobler A, Frazier K, Greiter-Wilke A, Herzyk D, Hough T, et al.
J Pharmacol Toxicol Methods
. 2019 May;
98:106579.
PMID: 31085319
This meeting report is based on presentations given at the first Drug Safety Africa Meeting in Potchefstroom, South Africa from November 20-22, 2018 at the North-West University campus. There were...
9.
Sukumar S, Wilson D, Yu Y, Wong J, Naravula S, Ermakov G, et al.
Cancer Res
. 2017 Jun;
77(16):4378-4388.
PMID: 28611044
GITR is a T-cell costimulatory receptor that enhances cellular and humoral immunity. The agonist anti-mouse GITR antibody DTA-1 has demonstrated efficacy in murine models of cancer primarily by attenuation of...
10.
Ponce R, Abad L, Amaravadi L, Gelzleichter T, Gore E, Green J, et al.
Regul Toxicol Pharmacol
. 2009 Apr;
54(2):164-82.
PMID: 19345250
An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and...