Necessity of MD study based on expected accumulation [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-05-10 13:55 (1560 d 04:27 ago) – Posting: # 18760
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Dear all,

the EMA requires multiple dose studies of prolonged release products if the mean AUCτ–∞ of both products after a single dose is >10% of AUC0–∞,1,2 whereas Health Canada was less restrictive (>20%).2,3 However, according to the current guidance of HC steady-state studies are not generally required.4

Discovered this goody about BE of extended release veterinary products:5,6,7

Kudos. Accumulation <2 (AUCτ–∞ <50% of AUC0–∞) is considered negligible. :thumb up:

  1. European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms. 20 November 2014. EMA/CPMP/EWP/280/96 Corr1.
  2. Scheerans C, Heinig R, Mueck W. Proposal for defining the relevance of drug accumulation derived from single dose study data for modified release dosage forms. Biopharm Drug Dis. 2015;36:93–103. doi:10.1002/bdd.1923. Open access.
  3. Health Canada, Health Products and Food Branch. Guidance for Industry. Conduct and Analysis of Bioavailability and Bioequivalence Studies – Part B: Oral Modified Release Formulations. 1996.
  4. Health Canada, Health Products and Food Branch. Guidance Document. Comparative Bioavailability Standards: Formulations Used for Systemic Effects. 22 May 2012. Online.
  5. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. Bioequivalence: Blood Level Bioequivalence Study. August 2015. VICH GL52.
  6. European Medicines Agency, Committee for Medicinal Products for Veterinary Use. VICH GL52. Bioequivalence: blood level bioequivalence study. 10 September 2015. EMA/CVMP/VICH/751935/2013 – Corr.1.
  7. Food and Drug Administration, Center for Veterinary Medicine. Guidance For Industry. Bioequivalence: Blood Level Bioequivalence Study. December 2016. VICH GL52.

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Helmut Schütz

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