Barbara M Davit

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration
    Barbara M Davit
    Division of Bioequivalence II, Office of Generic Drugs, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Derwood, MD 20855, USA
    Ann Pharmacother 43:1583-97. 2009
  2. pmc Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications
    Barbara M Davit
    US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, 7520 Standish Place, Rockville, Maryland 20855, USA
    AAPS J 10:148-56. 2008
  3. pmc Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration
    Barbara M Davit
    Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Metro Park North One, Rockville, Maryland 20855, USA
    AAPS J 14:915-24. 2012
  4. pmc Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA
    Anil K Nair
    Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Rockville, Maryland 20855, USA
    AAPS J 14:664-6. 2012
  5. pmc Dissolution testing for generic drugs: an FDA perspective
    Om Anand
    U S Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, Maryland 20855, USA
    AAPS J 13:328-35. 2011
  6. pmc Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA
    Qing Liu
    US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, Maryland 20855, USA
    AAPS J 14:19-22. 2012
  7. pmc Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration
    Bing V Li
    Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, USA
    AAPS J 15:10-4. 2013
  8. pmc Utility of physiologically based absorption modeling in implementing Quality by Design in drug development
    Xinyuan Zhang
    Office of Generic Drugs, Food and Drug Administration, Rockville, Maryland, USA
    AAPS J 13:59-71. 2011
  9. doi Generic drugs--safe, effective, and affordable
    John R Peters
    Office of Generic Drugs, U S Food and Drug Administration, Rockville, Maryland 20855, USA
    Dermatol Ther 22:229-40. 2009
  10. doi Bioequivalence study designs for generic solid oral anticancer drug products: scientific and regulatory considerations
    Paramjeet Kaur
    Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, MD, USA
    J Clin Pharmacol 53:1252-60. 2013

Collaborators

Detail Information

Publications12

  1. doi Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration
    Barbara M Davit
    Division of Bioequivalence II, Office of Generic Drugs, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Derwood, MD 20855, USA
    Ann Pharmacother 43:1583-97. 2009
    ..Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies...
  2. pmc Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications
    Barbara M Davit
    US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, 7520 Standish Place, Rockville, Maryland 20855, USA
    AAPS J 10:148-56. 2008
    ..We studied the scope of this issue within US generic drug regulatory submissions...
  3. pmc Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration
    Barbara M Davit
    Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Metro Park North One, Rockville, Maryland 20855, USA
    AAPS J 14:915-24. 2012
    ..The approach has been implemented successfully. To date, the RSABE approach has supported four full approvals and one tentative approval of HV generic drug products...
  4. pmc Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA
    Anil K Nair
    Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Rockville, Maryland 20855, USA
    AAPS J 14:664-6. 2012
    ..Antiallergic drugs in Class 1, drugs for pain relief in Class 2 and antidiabetic drugs in Class 3 have received the largest number of approvals during this period...
  5. pmc Dissolution testing for generic drugs: an FDA perspective
    Om Anand
    U S Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, Maryland 20855, USA
    AAPS J 13:328-35. 2011
    ..Thus, in vitro dissolution testing plays a major role in FDA's efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products...
  6. pmc Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA
    Qing Liu
    US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, Maryland 20855, USA
    AAPS J 14:19-22. 2012
    ..These approvals may be delayed if the BE portion of the submission is determined to be deficient. Many of these BE deficiencies recur commonly and can be avoided...
  7. pmc Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration
    Bing V Li
    Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, USA
    AAPS J 15:10-4. 2013
    ....
  8. pmc Utility of physiologically based absorption modeling in implementing Quality by Design in drug development
    Xinyuan Zhang
    Office of Generic Drugs, Food and Drug Administration, Rockville, Maryland, USA
    AAPS J 13:59-71. 2011
    ..In summary, a well-validated predictive model is a potentially useful tool for QbD implementation in drug development...
  9. doi Generic drugs--safe, effective, and affordable
    John R Peters
    Office of Generic Drugs, U S Food and Drug Administration, Rockville, Maryland 20855, USA
    Dermatol Ther 22:229-40. 2009
    ..Other factors in the dispensing of prescription medications that are not within the Food and Drug Administration regulatory authority are also mentioned...
  10. doi Bioequivalence study designs for generic solid oral anticancer drug products: scientific and regulatory considerations
    Paramjeet Kaur
    Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, MD, USA
    J Clin Pharmacol 53:1252-60. 2013
    ..The objective of this article is to illustrate the scientific and regulatory considerations in the design of BE studies for generic solid oral anticancer drug products through examples. ..
  11. doi Impact of Biopharmaceutics Classification System-based biowaivers
    Jack A Cook
    Department of Clinical Pharmacology, Specialty Care Business Unit, Pfizer Inc, New London, CT, USA
    Mol Pharm 7:1539-44. 2010
    ..If BCS class III compounds were also granted waivers, an additional direct savings of 62 to 71 million dollars would be realized, with 9 to 10 million dollars coming from HVDs...
  12. doi Use of in vitro-in vivo correlation to predict the pharmacokinetics of several products containing a BCS class 1 drug in extended release matrices
    Tahseen Mirza
    Food and Drug Administration Division of Product Quality Research, CDER OPS OTR DPQR, White Oak, LS Building 64 10903 New Hampshire Ave, Silver Spring, Maryland 20993, USA
    Pharm Res 30:179-90. 2013
    ..To determine if an IVIVC model can predict PK profiles of varying formulations of a BCS Class 1 drug that is a salt of a weak base...