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Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective

Advanced drug delivery reviews, 2022-11, Vol.190, p.114526, Article 114526

2022

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Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

CPT: pharmacometrics and systems pharmacology, 2023-05, Vol.12 (5), p.560-574

2023

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Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

CPT: pharmacometrics and systems pharmacology, 2023-05, Vol.12 (5), p.624-630

2023

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In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

The AAPS journal, 2015-07, Vol.17 (4), p.837-852

2015

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Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective

Advanced drug delivery reviews, 2022-10, Vol.189, p.114519-114519, Article 114519

2022

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Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective

The AAPS journal, 2019-03, Vol.21 (2), p.14-14, Article 14

2019

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Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug Products

The AAPS journal, 2017-03, Vol.19 (2), p.360-366

2017

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International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

The AAPS journal, 2015-05, Vol.17 (3), p.546-557

2015

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Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval

The AAPS journal, 2013-07, Vol.15 (3), p.875-883

2013

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Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case Studies

AAPS PharmSciTech, 2015-02, Vol.16 (1), p.5-9

2015

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In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases

The AAPS journal, 2009-09, Vol.11 (3), p.414-423

2009

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Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing

The AAPS journal, 2015-03, Vol.17 (2), p.370-379

2015

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A Sensitivity Analysis of the Modified Chi-square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution

The AAPS journal, 2013-04, Vol.15 (2), p.465-476

2013

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Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report

Journal of aerosol medicine and pulmonary drug delivery, 2011-06, Vol.24 (3), p.119

2011

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Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

The AAPS journal, 2013-01, Vol.15 (1), p.10-14

2013

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Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances

Journal of pharmaceutical sciences, 2024-09, Vol.113 (9), p.2708-2714

2024

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T lymphocytes and aortic aneurysms

Science China. Life sciences, 2014-08, Vol.57 (8), p.795-801

2014

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固体火箭超燃冲压发动机燃烧室初步实验研究

浙江大学学报：A卷英文版, 2017, Vol.18 (2), p.106-112

Zhong LV Zhi-xun XIA Bing LIU Li-ya HUANG

2017

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非线性粘弹性土中单桩沉降时间效应分析新方法

浙江大学学报：A卷英文版, 2015, Vol.16 (8), p.630-643

Zhen-ya LI Kui-hua WANG Shu-hui LV Wen-bing WU

2015

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Total anterior displacement of the vertebra of C2 without C2-3 locked joint and neurological deficit in Hangman＇s fracture

Chinese medical journal, 2009, Vol.122 (8), p.992-995

WANG Bing LV Guo-hua MA Ze-min KANG Yi-jun LI Jing CHEN Fei DENG You-wen LIU Wei-dong KUANG Lei

2009

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mTORC1 couples cyst(e)ine availability with GPX4 protein synthesis and ferroptosis regulation

Nature communications, 2021-03, Vol.12 (1), p.1589-1589, Article 1589

2021

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Building a green Belt and Road: A systematic review and comparative assessment of the Chinese and English-language literature

PloS one, 2020-09, Vol.15 (9), p.e0239009-e0239009

2020

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Genetic manipulation of gut microbes enables single-gene interrogation in a complex microbiome

Cell, 2022-02, Vol.185 (3), p.547-562.e22

2022

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The spatial coupling effect between urban street network's centrality and collection & delivery points: A spatial design network analysis-based study

PloS one, 2021-05, Vol.16 (5), p.e0251093-e0251093

2021

Volltextzugriff (PDF)

Electrically driven three-dimensional solitary waves as director bullets in nematic liquid crystals

Nature communications, 2018-07, Vol.9 (1), p.2912-10, Article 2912

2018

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Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective

Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective

Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug Products

International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval

Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case Studies

In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases

Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing

A Sensitivity Analysis of the Modified Chi-square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution

Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report

Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances

T lymphocytes and aortic aneurysms

固体火箭超燃冲压发动机燃烧室初步实验研究

非线性粘弹性土中单桩沉降时间效应分析新方法

Total anterior displacement of the vertebra of C2 without C2-3 locked joint and neurological deficit in Hangman＇s fracture

mTORC1 couples cyst(e)ine availability with GPX4 protein synthesis and ferroptosis regulation

Building a green Belt and Road: A systematic review and comparative assessment of the Chinese and English-language literature

Genetic manipulation of gut microbes enables single-gene interrogation in a complex microbiome

The spatial coupling effect between urban street network's centrality and collection & delivery points: A spatial design network analysis-based study

Electrically driven three-dimensional solitary waves as director bullets in nematic liquid crystals

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