585 results on '"Huang, Shiew-Mei"'
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52. Chapter 16 - Pharmacogenomic mechanisms of drug toxicity
53. Toward Bridging Unmet Medical Need in Early Alzheimer’s Disease: An Evaluation of Beta‐Amyloid (Aβ) Plaque Burden as a Potential Drug Development Tool
54. Predicting Nonlinear Pharmacokinetics of Omeprazole Enantiomers and Racemic Drug Using Physiologically Based Pharmacokinetic Modeling and Simulation: Application to Predict Drug/Genetic Interactions
55. Recommendations for selecting drug–drug interactions for clinical decision support
56. Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development.
57. Drug interactions evaluation: An integrated part of risk assessment of therapeutics
58. Cannabis for Medical Use: Clinical Pharmacology Perspectives on Scientific and Regulatory Challenges
59. Roadmap to 2030 for Drug Evaluation in Older Adults
60. Regulatory Science Perspectives on Transporter Studies in Drug Development
61. A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications (BLAs) for the assessment of target and antidrug antibodies effects
62. Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations
63. Roadmap to 2030 for Drug Evaluation in Older Adults.
64. AAPS Workshop Report: Strategies to Address Therapeutic Protein–Drug Interactions during Clinical Development
65. CYP-Mediated Therapeutic Protein-Drug Interactions: Clinical Findings, Proposed Mechanisms and Regulatory Implications
66. Towards Quantitation of the Effects of Renal Impairment and Probenecid Inhibition on Kidney Uptake and Efflux Transporters, Using Physiologically Based Pharmacokinetic Modelling and Simulations
67. Predicting Drug–Drug Interactions: An FDA Perspective
68. 3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration
69. Do Inhibitory Metabolites Impact DDI Risk Assessment? Analysis of in vitro and in vivo Data from NDA Reviews Between 2013 and 2018
70. Drug Interactions/Review: New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process
71. Improving pediatric dosing through pediatric initiatives: what we have learned
72. Governmental and Academic Efforts to Advance the Field of Pharmacogenomics
73. List of Contributors
74. The Role of Transporters in Drug Development: Regulatory Science Perspectives from the FDA
75. Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
76. Role of Pharmacogenetics in Registration Processes
77. Mechanisms and Genetics of Drug Transport
78. The Role of the FDA in Guiding Drug Development
79. Clinical Pharmacogenetics
80. Pharmacogenomic Mechanisms of Drug Toxicity
81. Contributors
82. Drug Interactions
83. Principles of Clinical Pharmacology, 3rd Edition
84. Bioavailability and Bioequivalence: An FDA Regulatory Overview
85. Optimizing Drug Development: Strategies to Assess Drug Metabolism/Transporter Interaction Potential—Toward a Consensus
86. Cannabis for Medical Use: Clinical Pharmacology Perspectives on Scientific and Regulatory Challenges.
87. Complex Drug Interactions: Significance and Evaluation
88. CONTRIBUTORS
89. ADVERSE DRUG REACTIONS AND INTERACTIONS
90. Utility of a physiologically–based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug–drug–disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice
91. PBPK as a tool in regulatory review
92. Transport and Metabolic Characterization of Caco-2 Cells Expressing CYP3A4 and CYP3A4 Plus Oxidoreductase
93. Application of Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Review
94. Population Pharmacokinetics: A Regulatory Perspective
95. Pharmacogenomics
96. Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine
97. Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology
98. Commentary on Fit-For-Purpose Models for Regulatory Applications
99. Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018‐2019 Submissions to the US FDA's Office of Clinical Pharmacology
100. Abstract CT086: Pneumonitis incidence in patients with non-small cell lung cancer treated with immunotherapy or chemotherapy in clinical trials and real-world data
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