FDA Approval Summary: Nalmefene Nasal Spray for the Emergency Treatment of Known or Suspected Opioid Overdose von Nallani, Srikanth C, Li, Zhihua, Florian, Jeffry, Xu, Yun, Sabarinath, Sreedharan, Brescia-Oddo, Tanya, Roca, Rigoberto A, Uppoor, Ramana S, Mehta, Mehul U

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An Innovative Pharmacometric Approach for the Simultaneous Analysis of Frequency, Duration and Severity of Migraine Events von Perez-Pitarch, Alejandro, Gottipati, Gopichand, Uppoor, Ramana, Mehta, Mehul, Sabarinath, Sreedharan

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Impact of the US FDA “Biopharmaceutics Classification System” (BCS) Guidance on Global Drug Development von 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

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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 von Zhu, Hao, Chen, Xiaomei, Ahmed, Mariam, Wang, Yaning, Liu, Qi, Uppoor, Ramana S., Kuemmel, Colleen, Mehta, Mehul

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Improving Pediatric Dosing Through Pediatric Initiatives: What We Have Learned von 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

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Exposure–response analyses of blood pressure and heart rate changes for methylphenidate in healthy adults von Li, Liang, Wang, Yaning, Uppoor, Ramana S., Mehta, Mehul U., Farchione, Tiffany, Mathis, Mitchell V., Zhu, Hao

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Shortened Positive and Negative Symptom Scale as an Alternate Clinical Endpoint for Acute Schizophrenia Trials: Analysis from the US Food & Drug Administration von Gopalakrishnan, Mathangi, Farchione, Tiffany, Mathis, Mitchell, Zhu, Hao, Mehta, Mehul, Uppoor, Ramana, Younis, Islam

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Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications von 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

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Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations von 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 von Younis, Islam R., Rogers, Hobart, Zhang, Huixia, Zhu, Hao, Uppoor, Ramana S., Mehta, Mehul U.

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Pediatric Extrapolation Approach for U.S. Food and Drug Administration Approval of Brexpiprazole in Patients Aged 13 to 17 Years with Schizophrenia von Zhang, Huixia, Liu, Jie, Sharma, Vishnu, Zhuang, Luning, Horn, Pamela, Uppoor, Ramana, Mehta, Mehul, Zhu, Hao

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Summary workshop report: Biopharmaceutics classification system—implementation challenges and extension opportunities von 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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Clinical Pharmacology in Drug Development for Rare Diseases in Neurology: Contributions and Opportunities von Abuasal, Bilal, Ahmed, Mariam A., Patel, Priyank, Albusaysi, Salwa, Sabarinath, Sreedharan, Uppoor, Ramana, Mehta, Mehul

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Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications von Younis, Islam R, Gopalakrishnan, Mathangi, Mathis, Mitchell, Mehta, Mehul, Uppoor, Ramana, Zhu, Hao, Farchione, Tiffany

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

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Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective von Fang, Lanyan, Uppoor, Ramana, Xu, Mingjiang, Sharan, Satish, Zhu, Hao, Tampal, Nilufer, Li, Bing, Zhang, Lei, Lionberger, Robert, Zhao, Liang

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

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Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective von Mehrotra, Shailly, Bhattaram, Atul, Krudys, Kevin, Bewernitz, Michael, Uppoor, Ramana, Mehta, Mehul, Liu, Tao, Sheridan, Philip, Hershkowitz, Norman, Kozauer, Nicholas, Bastings, Eric, Dunn, Billy, Men, Angela Yuxin

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Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder von Kalaria, Shamir N., Farchione, Tiffany R., Uppoor, Ramana, Mehta, Mehul, Wang, Yaning, Zhu, Hao

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Pharmacometric Bridging Approach for U.S. Food and Drug Administration Approval and Identification of Topiramate Dosing Regimen for Pediatric Patients 2-9 Years of Age With Epileps... von Marathe, Anshu, Liu, Chao, Kapcala, Leonard P., Hershkowitz, Norman, Men, Angela, Uppoor, Ramana, Mehta, Mehul, Wang, Yaning

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