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Partha Nandy

Explore the profile of Partha Nandy including associated specialties, affiliations and a list of published articles. Areas
Snapshot
Articles 37
Citations 398
Followers 0
Related Specialties
Pharmacology
General Medicine
Anesthesiology
Top 10 Co-Authors
An Vermeulen
Mahesh N Samtani
Xu Steven Xu
Liping Zhang
Kim Stuyckens
Holly Kimko
Adrian Dunne
Srihari Gopal
Alberto Russu
Fred Saad
Published In
Antimicrob Agents Chemother
Clin Pharmacokinet
AAPS J
J Clin Pharmacol
Anesth Analg
Affiliations
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Recent Articles
1.
Population Pharmacokinetic/Pharmacodynamic and Exposure-Response Modeling of Garadacimab in Healthy Volunteers and Patients With Hereditary Angioedema
Garcia R, Cheng S, Glassman F, Sharma A, De Miguel-Lillo B, Wiens M, et al.
CPT Pharmacometrics Syst Pharmacol . 2025 Mar; PMID: 40042097
Hereditary angioedema (HAE) is a rare genetic disease that manifests as recurrent, unpredictable, and potentially life-threatening attacks of angioedema. Garadacimab is a first-in-class, fully human, monoclonal antibody targeting activated factor...
2.
Model-Informed Clinical Development of 6-Monthly Injection of Paliperidone Palmitate in Patients with Schizophrenia: Dosing Strategies Guided by Population Pharmacokinetic Modeling and Simulation (Part II)
Tjollyn H, Venkatasubramanian R, Neyens M, Gopal S, Russu A, Nandy P, et al.
Eur J Drug Metab Pharmacokinet . 2024 May; 49(4):491-506. PMID: 38769284
Background And Objective: Paliperidone palmitate 6-month (PP6M) intramuscular (IM) injection is the longest-acting treatment available for patients with schizophrenia. A population pharmacokinetic (popPK) modeling and simulation approach was deployed to...
3.
Model-Informed Clinical Development of Once-Every-6-Month Injection of Paliperidone Palmitate in Patients with Schizophrenia: A Pharmacometric Bridging Approach (Part I)
Tjollyn H, Russu A, Venkatasubramanian R, Gopal S, Nandy P, Neyens M, et al.
Eur J Drug Metab Pharmacokinet . 2024 May; 49(4):477-489. PMID: 38750386
Background And Objective: A model-informed drug development (MIDD) approach was implemented for paliperidone palmitate (PP) 6-month (PP6M) clinical development, using pharmacokinetics and pharmacokinetic/pharmacodynamic model-based simulations. Methods: PP6M pharmacokinetics were simulated...
4.
Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression
Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets W, et al.
Clin Pharmacokinet . 2020 Oct; 60(4):501-516. PMID: 33128208
Background: Esketamine nasal spray is approved for treatment-resistant depression. Objective: The objective of this study was to characterize the pharmacokinetics of esketamine and noresketamine in healthy subjects and patients with...
5.
Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver
Zhu P, Hsu C, Hu C, Wong P, Sy S, Nandy P, et al.
AAPS J . 2020 Aug; 22(5):101. PMID: 32743691
The concentration-QTc (C-QTc) analysis is often applied in the first-in-human (FIH) study to demonstrate the absence of a QTc effect in support of a TQT waiver. However, a C-QTc analysis...
6.
Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation
Zhang L, Yan X, Fox K, Willmann S, Nandy P, Berkowitz S, et al.
J Thromb Thrombolysis . 2020 Apr; 50(1):20-29. PMID: 32323192
Rivaroxaban exposure and patient characteristics may affect the rivaroxaban benefit-risk balance. This study aimed to quantify associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in...
7.
Translational Model-Informed Dose Selection for a Human Positron Emission Tomography Imaging Study of JNJ-54175446, a P2X7 Receptor Antagonist
Xu Y, Miao X, Ravenstijn P, Hijzen A, Schmidt M, Nandy P, et al.
Clin Transl Sci . 2019 Oct; 13(2):309-317. PMID: 31642608
Positron emission tomography (PET) provides useful information in target engagement or receptor occupancy in the brain for central nervous system (CNS) drug development, however, dose selection for human PET studies...
8.
Influence of model-predicted rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome
Zhang L, Yan X, Nandy P, Willmann S, Fox K, Berkowitz S, et al.
Ther Adv Cardiovasc Dis . 2019 Aug; 13:1753944719863641. PMID: 31364490
Background: This analysis aimed to evaluate the impact of rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome (ACS) and to determine whether...
9.
Multiple daytime administration of the selective orexin-2 receptor antagonist JNJ-42847922 induces somnolence in healthy subjects without residual central effects
van der Ark P, Golor G, van Nueten L, Nandy P, de Boer P
J Psychopharmacol . 2018 Sep; 32(12):1330-1340. PMID: 30182786
Background: Pharmacokinetics, pharmacodynamics and general safety and tolerability of JNJ-42847922, a selective orexin-2 receptor antagonist, were assessed in healthy subjects. Methods: Five consecutive cohorts of healthy subjects were enrolled and...
10.
Evaluating Potential QT Effects of JNJ-54861911, a BACE Inhibitor in Single- and Multiple-Ascending Dose Studies, and a Thorough QT Trial With Additional Retrospective Confirmation, Using Concentration-QTc Analysis
Timmers M, Sinha V, Darpo B, Smith B, Brown R, Xue H, et al.
J Clin Pharmacol . 2018 Mar; 58(7):952-964. PMID: 29505101
Nonclinical assays with JNJ-54861911, a β-secretase 1 inhibitor have indicated that at high concentrations, it may delay cardiac repolarization. A 4-way crossover thorough QT (TQT) study was performed in 64...