Helmut
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Vienna, Austria,
2013-02-12 16:24
(4531 d 07:39 ago)

Posting: # 10004
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 FDA: new guidances expected in 2013 [BE/BA News]

Dear all,

FDA published their Guidance Agenda for 2013. Interesting:
  • Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications. General
    Consideration
  • Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products
  • Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in Abbreviated New Drug Applications
  • Bioanalytical Methods Validation

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jag009
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NJ,
2013-02-13 16:44
(4530 d 07:19 ago)

@ Helmut
Posting: # 10015
Views: 5,832
 

 FDA: new guidances expected in 2013

Hi Helmut,

❝ Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications. General Consideration


Do I smell them bringing back a 3-way food effect study (Test Fed, Ref Fed, Test Fast)?

John
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