Helmut
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2005-08-16 15:03
(6384 d 07:44 ago)

(edited by HS on 2007-08-24 14:22)
Posting: # 22
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 Updated Canadian Guidelines [Regulatives / Guidelines]

Dear all!

Canada's HPFB published a new set of Documents:
  • 12 May 2004, DRAFT GUIDANCE FOR INDUSTRY
    Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format (91kB PDF)
  • 28 May 2004, DRAFT GUIDANCE FOR INDUSTRY
    Use of Metabolite Data in Comparative Bioavailability Studies (27kB PDF)
  • 03 June 2005, NOTICE TO INDUSTRY
    Bioequivalence Requirements for Combination Drug Products (12kB PDF)
  • 08 June 2004, GUIDANCE FOR INDUSTRY
    Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State (25kB PDF)
  • 22 June 2005, NOTICE TO INDUSTRY
    Bioequivalence Requirements for Long Half-life Drugs (13kB PDF)
  • 22 June 2005, NOTICE TO INDUSTRY
    Bioequivalence Requirements for Drugs for Which an Early Time of Onset or Rapid Rate of Absorption Is Important (rapid onset drugs)
    (15kB PDF)
  • 31 May 2006, GUIDANCE FOR INDUSTRY
    Bioequivalence Requirements: Critical Dose Drugs (38kB PDF)
HTML-Versions of all Documents

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The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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