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Pharmacokinetics and Safety of a Novel Extended-Release Microsphere Formulation of Risperidone in Patients with Schizophrenia or Schizoaffective Disorder.

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Title: Pharmacokinetics and Safety of a Novel Extended-Release Microsphere Formulation of Risperidone in Patients with Schizophrenia or Schizoaffective Disorder.
Authors: Walling DP; CenExel - CNS, Garden Grove, CA, USA., Dong Y; Luye Pharma (USA), Ltd., Princeton, NJ, USA., Litman R; CBH Health, LLC, Gaithersburg, MD, USA.; Department of Psychiatry, Georgetown University Medical School, Washington DC, USA., Wang W; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China., Liu C; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China., Tai J; Luye Pharma (USA), Ltd., Princeton, NJ, USA., Liu P; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China., Shi Y; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China., Liu W; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China., Fu F; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China., Sun K; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China.
Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Mar; Vol. 65 (3), pp. 340-349. Date of Electronic Publication: 2024 Oct 15.
Publication Type: Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Pharmacokinetics and Safety of a Novel Extended-Release Microsphere Formulation of Risperidone in Patients with Schizophrenia or Schizoaffective Disorder.
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  Data: <searchLink fieldCode="AU" term="%22Walling+DP%22">Walling DP</searchLink>; CenExel - CNS, Garden Grove, CA, USA.<br /><searchLink fieldCode="AU" term="%22Dong+Y%22">Dong Y</searchLink>; Luye Pharma (USA), Ltd., Princeton, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Litman+R%22">Litman R</searchLink>; CBH Health, LLC, Gaithersburg, MD, USA.; Department of Psychiatry, Georgetown University Medical School, Washington DC, USA.<br /><searchLink fieldCode="AU" term="%22Wang+W%22">Wang W</searchLink>; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China.<br /><searchLink fieldCode="AU" term="%22Liu+C%22">Liu C</searchLink>; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China.<br /><searchLink fieldCode="AU" term="%22Tai+J%22">Tai J</searchLink>; Luye Pharma (USA), Ltd., Princeton, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Liu+P%22">Liu P</searchLink>; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China.<br /><searchLink fieldCode="AU" term="%22Shi+Y%22">Shi Y</searchLink>; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.<br /><searchLink fieldCode="AU" term="%22Liu+W%22">Liu W</searchLink>; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China.<br /><searchLink fieldCode="AU" term="%22Fu+F%22">Fu F</searchLink>; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China.<br /><searchLink fieldCode="AU" term="%22Sun+K%22">Sun K</searchLink>; School of Pharmacy, Yantai University, Yantai, Shandong, China.; Research & Development Center, Luye Pharma, Yantai, Shandong, China.; National Key Laboratory of Advanced Drug Delivery and Release Systems, Yantai, Shandong, China.
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  Data: <searchLink fieldCode="JN" term="%220366372%22">Journal of clinical pharmacology</searchLink> [J Clin Pharmacol] 2025 Mar; Vol. 65 (3), pp. 340-349. <i>Date of Electronic Publication: </i>2024 Oct 15.
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  Data: Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Wiley%22">Wiley </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>0366372 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1552-4604 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200912700%22">00912700 </searchLink><i>NLM ISO Abbreviation: </i>J Clin Pharmacol <i>Subsets: </i>MEDLINE
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      – TitleFull: Pharmacokinetics and Safety of a Novel Extended-Release Microsphere Formulation of Risperidone in Patients with Schizophrenia or Schizoaffective Disorder.
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              Text: 2025 Mar
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