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
Views: 2,726

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
[image]

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.

Dif-tor heh smusma 🖖 [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 11 (2 registered, 9 guests [including 4 identified bots]).
Forum time: Wednesday 18:22 CEST (Europe/Vienna)

There is no point in being precise when you don’t know
what you’re talking about.    attributed to John Tukey

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5