Docket Management
Docket: 01D-0488 - Draft Guidance - Food-effect Bioavail and Fed Bioequiv Studies
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Ms. Jenny Peters Date/Time 2002-01-28 14:22:23
Organization Global Regulatory Affairs; Pharmacia Corp
Category Company

Comments for FDA General
Questions
1. General Comments (28 January 2002) Dear Sir/Madam: Further to our comments sent earlier via Airborne (dated 24 January 2002), please note the following: 1. Lines 145-147: When both test product and RLD are rapidly dissolving, have similar dissolution profiles, and contain a drug substance with high solubility and high permeability (BCS Class I), as defined in the BCS guidance.... Comment - Should add: except where the RLD has food specific labeling. 2. Lines 152-153: When the label of the RLD does not make any statements about the effect of food on absorption or administration.... Comment - Should add: for BCS Class I drugs. As with our earlier submission, the line designations refer to the guidance document located at the Internet site: http://www.fda.gov/OHRMS/DOCKETS/98fr/010488g1.pdf. We noticed that there is another numbering of the guidance at http://www.fda.gov/cder/guidance/4613dft.PDF. We thank you for the opportunity to comment on this draft guidance. Please let us know if you have any questions on our review. Sincerely, Jenny Peters; Director; Global Regulatory Affairs; Global Regulatory Policy & Intelligence; Mail Stop 0636-298-112; Pharmacia Corporation; 7000 Portage Road; Kalamazoo, Michigan 49001; telephone: (616) 833-8141; facsimile: (616) 833-0512; jenny.l.peters@pharmacia.com;




EC -3