Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules

Por Subramaniam, Sriram, Patel, Devvrat, Davit, Barbara M., Conner, Dale P.
Publicado no AAPS J (2014)

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

Por Zhang, Xinyuan, Lionberger, Robert A., Davit, Barbara M., Yu, Lawrence X.
Publicado em 2011

Dissolution Testing for Generic Drugs: An FDA Perspective

Por Anand, Om, Yu, Lawrence X., Conner, Dale P., Davit, Barbara M.
Publicado em 2011

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

Por Davit, Barbara M., Kanfer, Isadore, Tsang, Yu Chung, Cardot, Jean-Michel
Publicado no AAPS J (2016)

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

Por Braddy, April C., Davit, Barbara M., Stier, Ethan M., Conner, Dale P.
Publicado no AAPS J (2014)

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

Por 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.
Publicado em 2012

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

Por 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.
Publicado em 2011

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

Por 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.
Publicado em 2008

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

Por 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.
Publicado em 2012

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

Por 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.
Publicado em 2012

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

Por 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.
Publicado em 2012

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

Por 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
Publicado em 2012