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RegisterUpdated Canadian Guidelines [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2005-08-16 15:03 (6821 d 02:42 ago) – Posting: # 22
Views: 14,561
(edited by HS on 2007-08-24 14:22)
Dear all!
Canada's HPFB published a new set of Documents:
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- 12 May 2004, DRAFT GUIDANCE FOR INDUSTRY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- 28 May 2004, DRAFT GUIDANCE FOR INDUSTRY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)
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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- Updated Canadian GuidelinesHelmut 2005-08-16 13:03 [Regulatives / Guidelines]
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Ing. Helmut Schütz