Bioequivalence and Bioavailability Forum • Updated Canadian Guidelines

Updated Canadian Guidelines [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2005-08-16 15:03 (6826 d 15:26 ago) – Posting: # 22
Views: 14,574
(edited by HS on 2007-08-24 14:22)

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12 May 2004, DRAFT GUIDANCE FOR INDUSTRY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28 May 2004, DRAFT GUIDANCE FOR INDUSTRY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)

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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