Nice numbers [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-06-21 13:05 (894 d 16:36 ago) – Posting: # 18944
Views: 5,845

Hi Beholder,

» But why did FDA deside to use 1/10 or 100,000 rule? […] 100,000 is just round number and that's all?

We find nice numbers which are “easy to remember” everywhere.See also the BE GL Section 4.1.2
  1. The test product should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified.
  2. The production of batches used should provide a high level of assurance that the product and process will be feasible on an industrial scale.
    In case of a production batch smaller than 100,000 units, a full production batch will be
(my emphasis)

prod. scale  full batch    10%    rule  biobatch
    50,000      yes        5,000    b     50,000
   100,000       no       10,000    a    100,000
 1,000,000       no      100,000    a    100,000
 5,000,000       no      500,000    a    500,000

Duno which justification you could give for a smaller biobatch under condition a).

Dif-tor heh smusma 🖖
Helmut Schütz

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

Complete thread:

 Admin contact
21,226 posts in 4,427 threads, 1,482 registered users;
online 2 (0 registered, 2 guests [including 1 identified bots]).
Forum time: Wednesday 05:42 UTC (Europe/Vienna)

A big data-analyst is an expert
in producing misleading conclusions from huge datasets.
It is much more efficient to use a statistician,
who can do the same with small ones.    Stephen Senn

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