Search Results - "Huang, S. M."

The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review by Huang, S‐M, Rowland, M

“…During regulatory review of clinical pharmacology data in new drug applications and biologics license applications, questions are routinely asked about how…”
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Transporters in Drug Development and Clinical Pharmacology by Giacomini, K M, Huang, S‐M

“…More than 400 membrane transporters in two major superfamilies—ATP‐binding cassette (ABC) and solute carrier (SLC)—are annotated in the human genome…”
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Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions by Zhao, P, Rowland, M, Huang, S-M

“…Physiologically based pharmacokinetic (PBPK) models are increasingly used by drug developers to evaluate the effect of patient factors on drug exposure…”
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Why Clinical Modulation of Efflux Transport at the Human Blood-Brain Barrier Is Unlikely: The ITC Evidence-Based Position by Kalvass, J C, Polli, J W, Bourdet, D L, Feng, B, Huang, S-M, Liu, X, Smith, Q R, Zhang, L K, Zamek-Gliszczynski, M J

“…Drug interactions due to efflux transport inhibition at the blood–brain barrier (BBB) have been receiving increasing scrutiny because of the theoretical…”
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The Role of Ethnicity in Variability in Response to Drugs: Focus on Clinical Pharmacology Studies by Yasuda, SU, Zhang, L, Huang, S‐M

“…Ethnicity is one factor that may account for the observed differences in both pharmacokinetics (PK) and pharmacodynamics (PD) of drugs, resulting in…”
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Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review by Zhao, P, Zhang, L, Grillo, JA, Liu, Q, Bullock, JM, Moon, YJ, Song, P, Brar, SS, Madabushi, R, Wu, TC, Booth, BP, Rahman, NA, Reynolds, KS, Gil Berglund, E, Lesko, LJ, Huang, S‐M

“…Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the pharmacokinetics of drugs in humans and evaluate the…”
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Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling by Huang, S‐M, Temple, R, Throckmorton, D C, Lesko, L J

“…One of the most effective ways in which regulatory agencies communicate with sponsors and guide drug development is through the issuance of guidances or…”
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Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials by Leong, R, Vieira, M L T, Zhao, P, Mulugeta, Y, Lee, C S, Huang, S-M, Burckart, G J

“…Physiologically based pharmacokinetic (PBPK) approaches that incorporate the developmental physiology and ontogeny of cytochrome P450 (CYP) enzymes may have…”
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Graphene-based counter electrode for dye-sensitized solar cells by Zhang, D.W., Li, X.D., Li, H.B., Chen, S., Sun, Z., Yin, X.J., Huang, S.M.

“…Graphene nanosheets (GNs) were synthesized and used as a substitute for platinum as counter-electrode materials for dye-sensitized solar cells (DSSCs). The…”
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PBPK Modeling of the Effect of Reduced Kidney Function on the Pharmacokinetics of Drugs Excreted Renally by Organic Anion Transporters by Hsueh, C‐H, Hsu, V, Zhao, P, Zhang, L, Giacomini, KM, Huang, S‐M

“…Altered pharmacokinetics (PK) in subjects with chronic kidney disease (CKD) may lead to dosing adjustment of certain drugs in subjects with CKD. It can be…”
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International Transporter Consortium Commentary on Clinically Important Transporter Polymorphisms by Giacomini, K M, Balimane, P V, Cho, S K, Eadon, M, Edeki, T, Hillgren, K M, Huang, S-M, Sugiyama, Y, Weitz, D, Wen, Y, Xia, C Q, Yee, S W, Zimdahl, H, Niemi, M

“…This Commentary focuses on genetic polymorphisms in membrane transporters. We present two polymorphisms for which there is a compelling body of literature…”
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Angiomotin decreases lung cancer progression by sequestering oncogenic YAP/TAZ and decreasing Cyr61 expression by Hsu, Y-L, Hung, J-Y, Chou, S-H, Huang, M-S, Tsai, M-J, Lin, Y-S, Chiang, S-Y, Ho, Y-W, Wu, C-Y, Kuo, P-L

“…Lung cancer is the leading cause of cancer death worldwide, with metastasis underlying majority of related deaths. Angiomotin (AMOT), a scaffold protein, has…”
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Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK by Wagner, C, Zhao, P, Pan, Y, Hsu, V, Grillo, J, Huang, SM, Sinha, V

“…The US Food and Drug Administration (FDA) public workshop, entitled “Application of Physiologically‐based Pharmacokinetic (PBPK) Modeling to Support Dose…”
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The UCSF-FDA TransPortal: A Public Drug Transporter Database by Morrissey, K M, Wen, C C, Johns, S J, Zhang, L, Huang, S-M, Giacomini, K M

“…Drug transporters play a key role in the absorption, distribution, and elimination of many drugs, and they appear to be important determinants of therapeutic…”
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Is This the Drug or Dose for You?: Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice by Huang, S‐M, Temple, R

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TOPK PBK promotes cell migration via modulation of the PI3K PTEN AKT pathway and is associated with poor prognosis in lung cancer by Shih, M-C, Chen, J-Y, Wu, Y-C, Jan, Y-H, Yang, B-M, Lu, P-J, Cheng, H-C, Huang, M-S, Yang, C-J, Hsiao, M, Lai, J-M

“…We integrated four gene expression profile data sets, namely two different pair-matched stage I lung adenocarcinoma data sets, secondary metastatic tumors vs…”
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Effects of Fe doping on the thermal hysteresis of the La0.5Ca0.5MnO3 system by Bhaskar, Ankam, Huang, M.-S, Liu, Chia-Jyi

“…A series of polycrystalline La 0.5 Ca 0.5 Mn 1− x Fe x O 3 ( x = 0.010, 0.025, 0.050, 0.075, 0.100, 0.125, 0.150, 0.175 and 0.200) was synthesized using a…”
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Therapeutic Protein-Drug Interactions and Implications for Drug Development by Huang, S‐M, Zhao, H, Lee, J‐I, Reynolds, K, Zhang, L, Temple, R, Lesko, L J

“…Many intrinsic and extrinsic factors can affect an individual patient's drug exposure and response.1 The US Food and Drug Administration (FDA) has published a…”
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Evaluation of Various Static In Vitro-In Vivo Extrapolation Models for Risk Assessment of the CYP3A Inhibition Potential of an Investigational Drug by Vieira, Md L T, Kirby, B, Ragueneau-Majlessi, I, Galetin, A, Chien, J Y L, Einolf, H J, Fahmi, O A, Fischer, V, Fretland, A, Grime, K, Hall, S D, Higgs, R, Plowchalk, D, Riley, R, Seibert, E, Skordos, K, Snoeys, J, Venkatakrishnan, K, Waterhouse, T, Obach, R S, Berglund, E G, Zhang, L, Zhao, P, Reynolds, K S, Huang, S-M

“…Nine static models (seven basic and two mechanistic) and their respective cutoff values used for predicting cytochrome P450 3A (CYP3A) inhibition, as…”
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Cytosolic PKM2 stabilizes mutant EGFR protein expression through regulating HSP90–EGFR association by Yang, Y-C, Cheng, T-Y, Huang, S-M, Su, C-Y, Yang, P-W, Lee, J-M, Chen, C-K, Hsiao, M, Hua, K-T, Kuo, M-L

“…Secondary mutation of epidermal growth factor receptor (EGFR) resulting in drug resistance is one of the most critical issues in lung cancer therapy. Several…”
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