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» Authors » Ofer Spiegelstein

Ofer Spiegelstein

Explore the profile of Ofer Spiegelstein including associated specialties, affiliations and a list of published articles. Areas
Snapshot
Articles 41
Citations 376
Followers 0
Related Specialties
Pharmacology
Neurology
Toxicology
Top 10 Co-Authors
Richard H Finnell
Laura Rabinovich-Guilatt
Anna Elgart
Orit Cohen-Barak
Bogdan Wlodarczyk
Merav Bassan
Boris Yagen
Stepan Melnyk
Nina Isoherranen
Edward Hellriegel
Published In
Clin Pharmacol Drug Dev
Br J Clin Pharmacol
Epilepsia
Br J Pharmacol
Toxicol Lett
Affiliations
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Recent Articles
1.
Population Pharmacokinetic Modeling and Simulation of TV-46000: A Long-Acting Injectable Formulation of Risperidone
Perlstein I, Merenlender Wagner A, Gomeni R, Lamson M, Harary E, Spiegelstein O, et al.
Clin Pharmacol Drug Dev . 2022 Mar; 11(7):865-877. PMID: 35245409
TV-46000 is a long-acting subcutaneous antipsychotic that uses a novel copolymer drug delivery technology in combination with a well-characterized molecule, risperidone, that is in clinical development as a treatment for...
2.
A Pharmacokinetic Bioequivalence Study of Fremanezumab Administered Subcutaneously Using an Autoinjector and a Prefilled Syringe
Cherniakov I, Cohen-Barak O, Tiver R, Gillespie M, Kessler Y, Gutierrez M, et al.
Clin Pharmacol Drug Dev . 2021 Jan; 10(9):1018-1027. PMID: 33411992
Fremanezumab (AJOVY; Teva Pharmaceutical Industries Ltd, Netanya, Israel), approved for the preventive treatment of migraine, is available as a subcutaneous injection either once a month or once every 3 months...
3.
The Effect of CYP3A Induction and Inhibition on the Pharmacokinetics of Laquinimod, a Novel Neuroimmunomodulator
Elgart A, Greenblatt D, Loupe P, Zur A, Weiss S, Mimrod D, et al.
Clin Pharmacol Drug Dev . 2020 Apr; 9(8):1015-1024. PMID: 32237115
Laquinimod, a neuroimmunomodulator, is extensively metabolized by cytochrome P450 (CYP) 3A4, and modulations of CYP3A4 activity may lead to alterations in the pharmacokinetics and/or clinical effects of laquinimod. To determine...
4.
Central nervous system effects of the histamine-3 receptor antagonist CEP-26401, in comparison with modafinil and donepezil, after a single dose in a cross-over study in healthy volunteers
Baakman A, Zuiker R, van Gerven J, Gross N, Yang R, Fetell M, et al.
Br J Clin Pharmacol . 2019 Feb; 85(5):970-985. PMID: 30710391
Aims: In previous studies, the histamine-3 receptor antagonist CEP-26401 had a subtle effect on spatial working memory, with the best effect seen at the lowest dose tested (20 μg), and...
5.
Pharmacokinetics and safety of single and multiple doses of rasagiline in healthy Japanese and caucasian subjects
Elgart A, Rabinovich-Guilatt L, Eyal E, Gross A, Spiegelstein O
Basic Clin Pharmacol Toxicol . 2018 Sep; 124(3):273-284. PMID: 30218626
As of March 2018, rasagiline is approved for the treatment of Parkinson disease in 55 countries including Japan. The present study evaluated the pharmacokinetics (PK) and safety of rasagiline in...
6.
The effect of laquinimod, a novel immuno-modulator in development to treat Huntington disease, on the pharmacokinetics of ethinylestradiol and levonorgestrel in healthy young women
Elgart A, Zur A, Mimrod D, Dror V, Bar-Ilan O, Korver T, et al.
Eur J Clin Pharmacol . 2018 Sep; 75(1):41-49. PMID: 30191262
Purpose: Laquinimod is an orally dosed immuno-modulator currently under development for Huntington's disease (HD). Preclinical findings suggest potential teratogenicity of laquinimod, thus the reproductive ability of females with HD treated...
7.
Pharmacokinetics, metabolism and safety of deuterated L-DOPA (SD-1077)/carbidopa compared to L-DOPA/carbidopa following single oral dose administration in healthy subjects
Schneider F, Erisson L, Beygi H, Bradbury M, Cohen-Barak O, Grachev I, et al.
Br J Clin Pharmacol . 2018 Jul; 84(10):2422-2432. PMID: 29959802
Aims: SD-1077, a selectively deuterated precursor of dopamine (DA) structurally related to L-3,4-dihydroxyphenylalanine (L-DOPA), is under development for treatment of motor symptoms of Parkinson's disease. Preclinical models have shown slower...
8.
A Thorough QT/QTc Study With Laquinimod, a Novel Immunomodulator in Development for Multiple Sclerosis and Huntington Disease
Spiegelstein O, Mimrod D, Rabinovich L, Eyal E, Sprenger C, Elgart A, et al.
Clin Pharmacol Drug Dev . 2018 May; 8(1):49-59. PMID: 29786964
In this randomized double-blind study, 4 groups of healthy subjects (50 per arm) participated to evaluate the effect of laquinimod, an oral treatment in development for multiple sclerosis and Huntington...
9.
A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects
Cohen-Barak O, Weiss S, Rasamoelisolo M, Faulhaber N, Yeung P, Loupe P, et al.
Cephalalgia . 2018 Apr; 38(13):1960-1971. PMID: 29667896
Objectives: The primary and secondary objectives of this phase 1 study were to evaluate the pharmacokinetic profile, safety, and immunogenicity of fremanezumab subcutaneous (sc) doses tested in phase 2 and...
10.
Effect of Food on the Pharmacokinetics of Single- and Multiple-Dose Hydrocodone Extended Release in Healthy Subjects
Bond M, Rabinovich-Guilatt L, Selim S, Darwish M, Tracewell W, Robertson Jr P, et al.
Clin Drug Investig . 2017 Sep; 37(12):1153-1163. PMID: 28948482
Background And Objectives: Food intake can alter the pharmacokinetics of certain medications, including changes in their oral bioavailability, which is of particular concern for extended-release (ER) opioids because of the...