Common bioanalytical deficiencies with bioequivalence submissions in Abbreviated New Drug Applications

• Published in: Bioanalysis Vol. 6; no. 4; pp. 441 - 445
• Main Authors: Williamson, Leah N, Conner, Dale P, Stier, Ethan M, Davit, Barbara M
• Format: Journal Article
• Language: English
• Published: England 01-02-2014
• Subjects: Databases, Factual; Drug Approval; Drug Delivery Systems; Drugs, Generic - pharmacokinetics; Government Regulation; Humans; Therapeutic Equivalency; Validation Studies as Topic
• ISSN: 1757-6180; 1757-6199
• DOI: 10.4155/bio.13.329

The US FDA published A Guidance for Industry: Bioanalytical Method Validation in May 2001. Despite the publication of the guidance, companies continue to submit bioequivalence studies with bioanalytical deficiencies that preclude Abbreviated New Drug Application approval. The Divisions of Bioequivalence in the FDA's Office of Generic Drugs conducted a survey of the bioequivalence submissions over a 10-year period (2001-2011) to identify the most commonly occurring bioanalytical deficiencies.
Data from a total of 4028 Abbreviated New Drug Application submissions were collected to identify bioanalytical deficiencies. Of the three categories of bioanalytical deficiencies (method, validation and report), the majority of the deficiencies were from the bioanalytical method validation section. Globally, the percentage of bioanalytical method validation deficiencies was 62%.
The approval of generic drugs would be accelerated if these deficiencies were avoided by generic companies by adhering to the guidance and therefore submitting a more complete application.