Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules

per Subramaniam, Sriram, Patel, Devvrat, Davit, Barbara M., Conner, Dale P.
Publicat a AAPS J (2014)

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

per Zhang, Xinyuan, Lionberger, Robert A., Davit, Barbara M., Yu, Lawrence X.
Publicat 2011

Dissolution Testing for Generic Drugs: An FDA Perspective

per Anand, Om, Yu, Lawrence X., Conner, Dale P., Davit, Barbara M.
Publicat 2011

BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements

per Davit, Barbara M., Kanfer, Isadore, Tsang, Yu Chung, Cardot, Jean-Michel
Publicat a AAPS J (2016)

Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products

per Braddy, April C., Davit, Barbara M., Stier, Ethan M., Conner, Dale P.
Publicat a AAPS J (2014)

Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA

per Nair, Anil K., Anand, Om, Chun, Nam, Conner, Dale P., Mehta, Mehul U., Nhu, Duong T., Polli, James E., Yu, Lawrence X., Davit, Barbara M.
Publicat 2012

Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA

per Liu, Qing, Davit, Barbara M., Cherstniakova, Svetlana A., Dandamudi, Suman, Walters, Johnetta F., Lee, Christina H., Raines, Kimberly W., Ren, Ke, Williamson, Leeh N., Conner, Dale P.
Publicat 2011

Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

per 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.
Publicat 2008

Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

per 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.
Publicat 2012

Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

per 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.
Publicat 2012

Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

per 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.
Publicat 2012

Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

per Polli, James E., Cook, Jack A., Davit, Barbara M., Dickinson, Paul A., Argenti, Domenick, Barbour, Nancy, García-Arieta, Alfredo, Geoffroy, Jean-Marie, Hartauer, Kerry, Li, Shoufeng, Mitra, Amitava, Muller, Francis X., Purohit, Vivek, Sanchez-Felix, Manuel, Skoug, John W., Tang, Kin
Publicat 2012