Search Results - "Samtani, Mahesh N"

Variations in the FRA10AC1 Fragile Site and 15q21 Are Associated with Cerebrospinal Fluid Aβ1-42 Level by Li, Qingqin S, Parrado, Antonio R, Samtani, Mahesh N, Narayan, Vaibhav A

“…Proteolytic fragments of amyloid and post-translational modification of tau species in Cerebrospinal fluid (CSF) as well as cerebral amyloid deposition are…”
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The ADAS-Cog revisited: Novel composite scales based on ADAS-Cog to improve efficiency in MCI and early AD trials by Raghavan, Nandini, Samtani, Mahesh N, Farnum, Michael, Yang, Eric, Novak, Gerald, Grundman, Michael, Narayan, Vaibhav, DiBernardo, Allitia

“…Abstract Background The Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) has been used widely as a cognitive end point in Alzheimer’s Disease (AD)…”
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Population Pharmacokinetics of Doripenem Based on Data from Phase 1 Studies with Healthy Volunteers and Phase 2 and 3 Studies with Critically Ill Patients by NANDY, Partha, SAMTANI, Mahesh N, LIN, Rachel

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Pharmacokinetic-Pharmacodynamic-Model-Guided Doripenem Dosing in Critically Ill Patients by Samtani, Mahesh N, Flamm, Robert, Kaniga, Koné, Nandy, Partha

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A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia by Coppola, Danielle, Liu, Yanning, Gopal, Srihari, Remmerie, Bart, Samtani, Mahesh N, Hough, David W, Nuamah, Isaac, Sulaiman, Ahmad, Pandina, Gahan

“…There are no previous reports of paliperidone palmitate's (PP) long term tolerability or pharmacokinetics of the highest dose in patients with schizophrenia…”
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Quantifying the pathophysiological timeline of Alzheimer's disease by Yang, Eric, Farnum, Michael, Lobanov, Victor, Schultz, Tim, Verbeeck, Rudi, Raghavan, Nandini, Samtani, Mahesh N, Novak, Gerald, Narayan, Vaibhav, DiBernardo, Allitia

“…Hypothetical models of AD progression typically relate clinical stages of AD to sequential changes in CSF biomarkers, imaging, and cognition. However,…”
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Population Pharmacokinetics of Intramuscular Paliperidone Palmitate in Patients with Schizophrenia: A Novel Once-Monthly, Long-Acting Formulation of an Atypical Antipsychotic by Samtani, Mahesh N., Vermeulen, An, Stuyckens, Kim

“…Objectives To characterize the population pharmacokinetics of paliperidone after intramuscular administration of its long-acting palmitate ester at various…”
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Efficacy and safety of glucagon‐like peptide‐1/glucagon receptor co‐agonist JNJ‐64565111 in individuals with obesity without type 2 diabetes mellitus: A randomized dose‐ranging study by Alba, Maria, Yee, Jaqueline, Frustaci, Mary Ellen, Samtani, Mahesh N., Fleck, Penny

“…Summary Individuals with obesity have a heightened risk of developing serious comorbidities, and pharmacological treatments for people with obesity are…”
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Quantification of dexamethasone and corticosterone in rat biofluids and fetal tissue using highly sensitive analytical methods: assay validation and application to a pharmacokinetic study by Samtani, Mahesh N., Jusko, William J.

“…A sensitive, specific, accurate and precise LC/MS/MS method was developed for the simultaneous measurement of dexamethasone and corticosterone in rat plasma…”
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BETAMETHASONE PHARMACOKINETICS AFTER TWO PRODRUG FORMULATIONS IN SHEEP: IMPLICATIONS FOR ANTENATAL CORTICOSTEROID USE by SAMTANI, Mahesh N, LÖHLE, Matthias, GRANT, Angela, NATHANIELSZ, Peter W, JUSKO, William J

“…Maternal administration of betamethasone to enhance fetal lung maturation for women who threaten preterm labor is common clinical practice. However,…”
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Pharmacokinetic-Pharmacodynamic Characterization of Relapse Risk for Paliperidone Palmitate 1-Month and 3-Month Formulations by Russu, Alberto, Savitz, Adam, Mathews, Maju, Gopal, Srihari, Feng, Yu, Samtani, Mahesh N

“…Pharmacokinetic-pharmacodynamic (PK/PD) models were developed to describe the relationship between the time course of paliperidone plasma concentrations and…”
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Pharmacodynamic Profiling of Ceftobiprole for Treatment of Complicated Skin and Skin Structure Infections by Kimko, Holly, Xu, Xu, Nandy, Partha, Samtani, Mahesh N, Strauss, Richard S, Bagchi, Partha, Noel, Gary J

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Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: A phase-1, single-dose, randomized, open-label study by Ravenstijn, Paulien, Remmerie, Bart, Savitz, Adam, Samtani, Mahesh N., Nuamah, Isaac, Chang, Cheng-Tao, De Meulder, Marc, Hough, David, Gopal, Srihari

“…This multicenter, randomized, open‐label, parallel‐group, phase‐1 study assessed the pharmacokinetics (PK), safety, and tolerability of the investigational…”
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Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program by Galluppi, Gerald R., Ahamadi, Malidi, Bhattacharya, Souvik, Budha, Nageshwar, Gheyas, Ferdous, Li, Chi‐Chung, Chen, Yuan, Dosne, Anne‐Gaëlle, Kristensen, Niels Rode, Magee, Mindy, Samtani, Mahesh N., Sinha, Vikram, Taskar, Kunal, Upreti, Vijay V., Yang, Jianning, Cook, Jack

“…A recent industry perspective published in this journal describes the benefits received by drug companies from participation in the MIDD Pilot Program. Along…”
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An Improved Model for Disease Progression in Patients From the Alzheimer's Disease Neuroimaging Initiative by Samtani, Mahesh N., Farnum, Michael, Lobanov, Victor, Yang, Eric, Raghavan, Nandini, DiBernardo, Allitia, Narayan, Vaibhav

“…The objective of this analysis was to develop a semi-mechanistic nonlinear disease progression model using an expanded set of covariates that captures the…”
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Rivaroxaban, a direct Factor Xa inhibitor, versus acetylsalicylic acid as thromboprophylaxis in children post–Fontan procedure: Rationale and design of a prospective, randomized trial (the UNIVERSE study) by Pina, Liza Miriam, Dong, Xiangwen, Zhang, Liping, Samtani, Mahesh N., Michelson, Alan D., Justino, Henri, Bonnet, Damien, Harris, Kevin C., Jefferies, John, McCrindle, Brian W., Li, Jennifer S.

“…The Fontan procedure is the final step of the 3-stage palliative procedure commonly performed in children with single ventricle physiology. Thrombosis remains…”
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Model-Informed Clinical Development of Once-Every-6-Month Injection of Paliperidone Palmitate in Patients with Schizophrenia: A Pharmacometric Bridging Approach (Part I) by T’jollyn, Huybrecht, Russu, Alberto, Venkatasubramanian, Raja, Gopal, Srihari, Nandy, Partha, Neyens, Martine, Faelens, Ruben, Samtani, Mahesh N., Ackaert, Oliver, Perez-Ruixo, Juan Jose

“…Background and Objective A model-informed drug development (MIDD) approach was implemented for paliperidone palmitate (PP) 6-month (PP6M) clinical development,…”
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Modeling glucocorticoid-mediated fetal lung maturation: I. Temporal patterns of corticosteroids in rat pregnancy by Samtani, Mahesh N, Pyszczynski, Nancy A, Dubois, Debra C, Almon, Richard R, Jusko, William J

“…Preterm birth produces neonatal respiratory distress syndrome, and dexamethasone (DEX) is administered maternally to induce fetal lung maturation in women at…”
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Comparison of dexamethasone pharmacokinetics in female rats after intravenous and intramuscular administration by Samtani, Mahesh N., Jusko, William J.

“…This study seeks a route of drug administration that would produce a pharmacokinetic profile for dexamethasone not significantly different from the intravenous…”
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Dosing and Switching Strategies for Paliperidone Palmitate: Based on Population Pharmacokinetic Modelling and Clinical Trial Data by Samtani, Mahesh N., Gopal, Srihari, Gassmann-Mayer, Cristiana, Alphs, Larry, Palumbo, Joseph M.

“…Paliperidone palmitate is a second-generation, long-acting injectable (LAI) antipsychotic recently approved by the US FDA and European Medicines Agency for use…”
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