Nice numbers [Regulatives / Guidelines]
Hi Beholder,
We find nice numbers which are “easy to remember” everywhere.
Duno which justification you could give for a smaller biobatch under condition a).
❝ 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.
- When the transition from analysis of untransformed [limits 80–120%] to log-transformed data was made, we had serious discussions about how the new limits should be defined. There were three parties (all considering a ∆ of 20% as not clinically relevant):
1. L=1–∆, U=(1–∆)–1 or 80–125%.
2. U=1+∆, L=(1+∆)–1 or 83⅓–120%.
3. U–L 0.4 as the old one or ~81.98043–121.98033%.
The 1st party won because of the nice numbers.
- Critical dose drugs in Canada. ∆ 10% (like for the EMA). Lower limit 1–∆=90.0% (only one decimal place); upper limit not 111.11% but 112.0%.
- k in ABEL based on the switching CVwR 30% not \(\log{(1.25)}/\sqrt{\log{(0.30^2+1)}} = 0.7601283\ldots \) but rounded to 0.76.
- 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.
- 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
required.
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).
—
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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Complete thread:
- FDA: Size of bio-batch Helmut 2013-12-10 14:05 [Regulatives / Guidelines]
- FDA: Size of bio-batch jag009 2013-12-10 20:03
- FDA: antique of ’93 Helmut 2013-12-10 23:32
- FDA: antique of ’93 jag009 2013-12-11 15:23
- FDA: antique of ’93 Helmut 2013-12-11 15:26
- FDA: antique of ’93 jag009 2013-12-11 16:21
- FDA: antique of ’93 Helmut 2013-12-11 16:29
- FDA: antique of ’93 jag009 2013-12-11 23:16
- Patience Helmut 2013-12-12 14:34
- FDA: antique of ’93 jag009 2013-12-11 23:16
- FDA: antique of ’93 Helmut 2013-12-11 16:29
- FDA: antique of ’93 jag009 2013-12-11 16:21
- FDA: antique of ’93 Helmut 2013-12-11 15:26
- FDA: antique of ’93 Beholder 2018-06-21 09:21
- Nice numbersHelmut 2018-06-21 15:05
- Nice numbers Beholder 2018-06-22 10:33
- Type II variation Helmut 2018-06-22 15:12
- Nice numbers Beholder 2018-06-22 10:33
- Birdsong's third law of BE ElMaestro 2018-06-22 10:10
- Experience Beholder 2018-06-22 11:04
- Why, oh why? Helmut 2018-06-22 15:17
- Sorry for the delay Beholder 2018-10-18 09:40
- Why, oh why? Helmut 2018-06-22 15:17
- Experience Beholder 2018-06-22 11:04
- Nice numbersHelmut 2018-06-21 15:05
- FDA: antique of ’93 jag009 2013-12-11 15:23
- FDA: antique of ’93 Helmut 2013-12-10 23:32
- FDA: Size of bio-batch jag009 2013-12-10 20:03