Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance von Booth, Brian, Arnold, Mark E., DeSilva, Binodh, Amaravadi, Lakshmi, Dudal, Sherri, Fluhler, Eric, Gorovits, Boris, Haidar, Sam H., Kadavil, John, Lowes, Steve, Nicholson, Robert, Rock, Marie, Skelly, Michael, Stevenson, Lauren, Subramaniam, Sriram, Weiner, Russell, Woolf, Eric

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Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration von Davit, Barbara M, Nwakama, Patrick E, Buehler, Gary J, Conner, Dale P, Haidar, Sam H, Patel, Devvrat T, Yang, Yongsheng, Yu, Lawrence X, Woodcock, Janet

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Regulatory efforts in response to a decade of scientific advancement in bioanalytical methods von Haidar, Sam H

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Evaluation of stability using one versus three tubes for each quality control concentration in matrix-based bioanalysis von Haidar, Sam H, Shakleya, Diaa, Wang, Jiang, Cai, Xiaohan, Faustino, Patrick

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Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir von Vaithianathan, Soundarya, Haidar, Sam H., Zhang, Xinyuan, Jiang, Wenlei, Avon, Christopher, Dowling, Thomas C., Shao, Changxing, Kane, Maureen, Hoag, Stephen W., Flasar, Mark H., Ting, Tricia Y., Polli, James E.

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Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration von Davit, Barbara M., Chen, Mei-Ling, Conner, Dale P., Haidar, Sam H., Kim, Stephanie, Lee, Christina H., Lionberger, Robert A., Makhlouf, Fairouz T., Nwakama, Patrick E., Patel, Devvrat T., Schuirmann, Donald J., Yu, Lawrence X.

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Bioequivalence Approaches for Highly Variable Drugs and Drug Products von Haidar, Sam H., Davit, Barbara, Chen, Mei-Ling, Conner, Dale, Lee, LaiMing, Li, Qian H., Lionberger, Robert, Makhlouf, Fairouz, Patel, Devvrat, Schuirmann, Donald J., Yu, Lawrence X.

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Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs von Haidar, Sam H., Makhlouf, Fairouz, Schuirmann, Donald J., Hyslop, Terry, Davit, Barbara, Conner, Dale, Yu, Lawrence X.

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Bioanalytical Inspections: Organizational Changes and Regulatory Perspectives von Haidar, Sam H, Scheibner, Kara A

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Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications von Davit, Barbara M., Conner, Dale P., Fabian-Fritsch, Beth, Haidar, Sam H., Jiang, Xiaojian, Patel, Devvrat T., Seo, Paul R. H., Suh, Keri, Thompson, Christina L., Yu, Lawrence X.

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Reply to “On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs” von Vaithianathan, Soundarya, Haidar, Sam H., Zhang, Xinyuan, Jiang, Wenlei, Avon, Christopher, Dowling, Thomas C., Shao, Changxing, Kane, Maureen, Hoag, Stephen W., Flasar, Mark H., Ting, Tricia Y., Polli, James E.

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Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration von Li, Bing V., Davit, Barbara M., Lee, Christina H., Pabba, Santhosh K., Mahadevan, Chitra, Caramenico, Hoainhon T., Haidar, Sam H, Sanchez, Aida L., Sigler, Aaron W., Stier, Ethan M., Conner, Dale P.

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Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir: Pharmacokinetics, Pharmacodynamics and Dru... von Vaithianathan, Soundarya, Haidar, Sam H, Zhang, Xinyuan, Jiang, Wenlei, Avon, Christopher, Dowling, Thomas C, Shao, Changxing, Kane, Maureen, Hoag, Stephen W, Flasar, Mark H, Ting, Tricia Y, Polli, James E

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RECENT ADVANCES IN THE EVALUATION OF BIOEQUIVALENCE von Haidar, Sam H.

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Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs von Haidar, Sam H., Makhlouf, Fairouz, Schuirmann, Donald J., Hyslop, Terry, Davit, Barbara, Conner, Dale, Yu, Lawrence X.

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Comparing Generic and Innovator Drugs: A Review of I2 Years of Bioequivalence Data from the United States Food and Drug Administration von DAVIT, Barbara M, NWAKAMA, Patrick E, BUEHLER, Gary J, CONNER, Dale P, HAIDAR, Sam H, PATEL, Devvrat T, YONGSHENG YANG, YU, Lawrence X, WOODCOCK, Janet

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Modeling the pharmacokinetics and pharmacodynamics of a unique oral hypoglycemic agent using neural networks von HAIDAR, Sam H, JOHNSON, Steven B, FOSSLER, Michael J, HUSSAIN, Ajaz S

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Evaluating a Possible Pharmacokinetic Interaction between Remifentanil and Esmolol in the Rat von Haidar, Sam H., Moreton, Julian E., Liang, Zhongming, Hoke, John F., Muir, Keith T., EddingtonX, Natalie D.

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The pharmacokinetics and electroencephalogram response of remifentanil alone and in combination with esmolol in the rat von HAIDAR, S. H, MORETON, J. E, LIANG, Z, HOKE, J. F, MUIR, K. T, EDDINGTON, N. D

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Determination of remifentanil, an ultra-short-acting opioid anesthetic, in rat blood by high performance liquid chromatography with ultraviolet detection von Haidar, Sam H., Liang, Zhongming, Selinger, Krzysztof, Hamlett, LuWanda, Eddington, Natalie D.

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