CFDA: Yet another story? [RSABE / ABEL]
Hi libaiyi,
Weird – do you have a reference? Feel free to post in Chinese; we have some native speakers here.
This would add another story to the two we already have (see this thread in all of its beauty). I have some doubts whether that is really what the CFDA wants. Would be a step back to what was used in some European countries 25+ years ago.
First you have to clarify which method for HVD(P)s the CFDA accepts.
❝ I want to know how to figure out that whether the results are bioequivalence?
- If the 90% CI of the GMR lies entirely within the (expanded) BE limits
⇒ bioequivalence demonstrated with p ≤0.05.
- If at least one of the confidence limits is outside the (expanded) BE limits
⇒ indecisive (BE not demonstrated due to lacking power; may be possible in another study with a higher sample size).
- If the 90% CI of the GMR lies entirely outside the (expanded) BE limits (i.e., lower CL > upper limit or upper CL < lower limit)
⇒ bioinequivalence proven with p ≤0.05. Don’t perform another study: Reformulate.
❝ According to CFDA (China Food and Drug Administration) guidelines, when CVwR of Cmax is larger than 0.3, BE limits are fixed at (69.83, 143.19).
Weird – do you have a reference? Feel free to post in Chinese; we have some native speakers here.

This would add another story to the two we already have (see this thread in all of its beauty). I have some doubts whether that is really what the CFDA wants. Would be a step back to what was used in some European countries 25+ years ago.
❝ Can we use the results from Mixed Model by SAS directly to determine if it falls between the limits or not?
First you have to clarify which method for HVD(P)s the CFDA accepts.
- Like the EMA (ABEL): SAS-code given in the Q&A-document.
Proc GLM
, notProc Mixed
.
- Like the FDA (RSABE): SAS-code given in the progesterone guidance. Decision not based on the “implied” scaled limits but the upper 95% confidence bound of (YT – YR)2 – θs²wR must be ≤0.
Proc Mixed
for full replicate studies (TRTR|RTRT, TTRR|RRTT, or TRT|RTR) andProc GLM
for partial replicate studies (TRR|RTR|RRT).
If swR <0.294 (conventional ABE)Proc Mixed
and BE if 90% CI within 80.00–125.00%.
- Your story:
Proc Mixed
if the CFDA follows the FDA orProc GLM
if like the EMA.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
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Complete thread:
- Calculate the BE limits for HVDPs based on EMA libaiyi 2018-06-08 11:41 [RSABE / ABEL]
- Calculate the BE limits for HVDPs based on EMA Shuanghe 2018-06-08 12:51
- (Expanded) BE limits, EMA-style Helmut 2018-06-08 13:19
- (Expanded) BE limits, EMA-style libaiyi 2018-06-11 07:21
- CFDA: Yet another story?Helmut 2018-06-11 12:24
- CFDA: Yet another story? libaiyi 2018-06-12 11:09
- CFDA: Draft guidance? Helmut 2018-06-12 14:54
- CFDA: Draft guidance? libaiyi 2018-06-13 03:39
- Hypotheses generated “in face of the data” Helmut 2018-06-13 11:39
- Hypotheses generated “in face of the data” libaiyi 2018-06-14 03:46
- Hypotheses generated “in face of the data” Helmut 2018-06-13 11:39
- CFDA: Draft guidance? libaiyi 2018-06-13 03:39
- CFDA: Draft guidance? Helmut 2018-06-12 14:54
- CFDA: Yet another story? libaiyi 2018-06-12 11:09
- CFDA: Yet another story?Helmut 2018-06-11 12:24
- (Expanded) BE limits, EMA-style libaiyi 2018-06-11 07:21