Docket Management
Docket: 01D-0488 - Draft Guidance - Food-effect Bioavail and Fed Bioequiv Studies
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Jenny Peters Date/Time 2002-01-28 13:48:17
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 We thank you for the opportunity to comment on this draft guidance.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 -1