Nice numbers [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-06-21 15:05 (1559 d 16:35 ago) – Posting: # 18944
Views: 7,628

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 🖖 Довге життя Україна! [image]
Helmut Schütz

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

Complete thread:

UA Flag
 Admin contact
22,391 posts in 4,685 threads, 1,595 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Wednesday 07:41 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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