Search Results - "Uppoor, Ramana S"

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH by Zhu, Hao, Chen, Xiaomei, Ahmed, Mariam, Wang, Yaning, Liu, Qi, Uppoor, Ramana S., Kuemmel, Colleen, Mehta, Mehul

“…In this paper, a special case for bioequivalence evaluation of oral formulations is discussed. Drug formulations with different forms of active moieties (e.g.,…”
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Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications by Bhattaram, Venkatesh A, Booth, Brian P, Ramchandani, Roshni P, Beasley, B Nhi, Wang, Yaning, Tandon, Veneeta, Duan, John Z, Baweja, Raman K, Marroum, Patrick J, Uppoor, Ramana S, Rahman, Nam Atiqur, Sahajwalla, Chandrahas G, Powell, J Robert, Mehta, Mehul U, Gobburu, Jogarao V S

“…The value of quantitative thinking in drug development and regulatory review is increasingly being appreciated. Modeling and simulation of data pertaining to…”
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Impact of the US FDA “Biopharmaceutics Classification System” (BCS) Guidance on Global Drug Development by Mehta, Mehul U, Uppoor, Ramana S, Conner, Dale P, Seo, Paul, Vaidyanathan, Jayabharathi, Volpe, Donna A, Stier, Ethan, Chilukuri, Dakshina, Dorantes, Angelica, Ghosh, Tapash, Mandula, Haritha, Raines, Kimberly, Dhanormchitphong, Pariban, Woodcock, Janet, Yu, Lawrence X

“…The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August…”
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Improving Pediatric Dosing Through Pediatric Initiatives: What We Have Learned by Rodriguez, William, Selen, Arzu, Avant, Debbie, Chaurasia, Chandra, Crescenzi, Terrie, Gieser, Gerlie, Di Giacinto, Jennifer, Huang, Shiew-Mei, Lee, Peter, Mathis, Lisa, Murphy, Dianne, Murphy, Shirley, Roberts, Rosemary, Sachs, Hari Cheryl, Suarez, Sandra, Tandon, Veneeta, Uppoor, Ramana S

“…The goal was to review the impact of pediatric drug studies, as measured by the improvement in pediatric dosing and other pertinent information captured in the…”
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Exposure–response analyses of blood pressure and heart rate changes for methylphenidate in healthy adults by Li, Liang, Wang, Yaning, Uppoor, Ramana S., Mehta, Mehul U., Farchione, Tiffany, Mathis, Mitchell V., Zhu, Hao

“…The aim of the study was to evaluate the exposure–response (E–R) relationships of blood pressure (BP) and heart rate (HR) changes in healthy adults taking…”
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Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations by Stier, Ethan M., Davit, Barbara M., Chandaroy, Parthapratim, Chen, Mei-Ling, Fourie-Zirkelbach, Jeanne, Jackson, Andre, Kim, Stephanie, Lionberger, Robert, Mehta, Mehul, Uppoor, Ramana S., Wang, Yaning, Yu, Lawrence, Conner, Dale P.

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An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: Review of recent cases in psychiatry drugs by Younis, Islam R., Rogers, Hobart, Zhang, Huixia, Zhu, Hao, Uppoor, Ramana S., Mehta, Mehul U.

“…Clinical pharmacology as an interdisciplinary science is unique in its capacity and the diversity of the methods and approaches it can provide to derive dosing…”
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Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities by Polli, James E, Yu, Lawrence X, Cook, Jack A, Amidon, Gordon L, Borchardt, Ronald T, Burnside, Beth A, Burton, Philip S, Chen, Mei-Ling, Conner, Dale P, Faustino, Patrick J, Hawi, Amale A, Hussain, Ajaz S, Joshi, Hemant N, Kwei, Gloria, Lee, Vincent H L, Lesko, Lawrence J, Lipper, Robert A, Loper, Alice E, Nerurkar, Shriniwas G, Polli, Joseph W, Sanvordeker, Dilip R, Taneja, Rajneesh, Uppoor, Ramana S, Vattikonda, Chandra S, Wilding, Ian, Zhang, Guohua

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Effect of Ethanol on Opioid Drug Permeability Through Caco-2 Cell Monolayers by Volpe, Donna A., Asafu-Adjaye, Ebenezer B., Ellison, Christopher D., Doddapaneni, Suresh, Uppoor, Ramana S., Khan, Mansoor A.

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Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations by Uppoor, Venkata Ramana S

“…In vitro dissolution has been extensively used as a quality control tool for solid oral dosage forms. In several cases, however, it is not known whether one…”
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In vivo drug-drug interaction studies- A survey of all new molecular entities approved from 1987 to 1997 by Marroum, Patrick J., Uppoor, Ramana S., Parmelee, Thomas, Ajayi, Funmilayo, Burnett, Alfreda, Yuan, Rae, Svadjian, Raffi, Lesko, Lawrence J., Balian, John D.

“…Ninety‐eight new molecular entities applications approved between 1987 to 1991 (period I) and 193 applications for new molecular entities between 1992 to 1997…”
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A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH by Zhu, Hao, Chen, Xiaomei, Ahmed, Mariam, Wang, Yaning, Liu, Qi, Uppoor, Ramana S., Kuemmel, Colleen, Mehta, Mehul

“…Not provided…”
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In vitro metabolic interaction studies: Experience of the Food and Drug Administration by Yuan, Rae, Parmelee, Thomas, Balian, John D., Uppoor, Ramana S., Ajayi, Funmilayo, Burnett, Alfreda, Lesko, Larry J., Marroum, Patrick

“…A total of 194 new molecular entities approved by the Food and Drug Administration between 1992 and 1997 were surveyed to determine the role of in vitro…”
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Selective complexing agents designed after adenosine receptor as percutaneous permeation enhancers of drugs by Uppoor, Venkata Ramana S., Shah, Jaymin C.

“…The objective was to evaluate selective complexing agents, naphthalene diamide diimide (I) and naphthalene diester diimide (II), as transport facilitators of…”
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