Helmut
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Vienna, Austria,
2020-12-30 10:37
(18 d 19:50 ago)

Posting: # 22160
Views: 445
 

 Chinese BE GL [Regulatives / Guidelines]

Dear all,

does anybody know where to find the current GL of the Centre of Drug Evaluation? Google-translate gives up at http://www.cde.org.cn/.

Dif-tor heh smusma 🖖
Helmut Schütz
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ElMaestro
★★★

Denmark,
2020-12-30 10:54
(18 d 19:33 ago)

@ Helmut
Posting: # 22161
Views: 384
 

 Chinese BE GL

Hi Hötzi,

» does anybody know where to find the current GL of the Centre of Drug Evaluation? Google-translate gives up at http://www.cde.org.cn/.

Yes the website is a kind of challenge for the liguistically imparied, such as myself.

Here's a cheat proposal: Go to the Taiwanese regulator, and find this document.

Might not be the exact document you are looking for, but have a look around anyway, you may find what you need.

:cool:

Pass or fail!
ElMaestro
Helmut
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Vienna, Austria,
2020-12-30 11:16
(18 d 19:12 ago)

@ ElMaestro
Posting: # 22162
Views: 379
 

 Chinese BE GL

Hi ElMaestro,

» Yes the website is a kind of challenge for the liguistically imparied, such as myself.

Welcome to the club.

» Here's a cheat proposal: Go to the Taiwanese regulator, and find this document.

THX, but I’m looking for [image] not [image] …

Acc. to this post China follows the FDA’s RSABE. I have only the Chinese Pharmacopia of 2015 (EMA’s ABEL) and the BE-GL of 2016 (nothing about HVDs).

Dif-tor heh smusma 🖖
Helmut Schütz
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mittyri
★★  

Russia,
2020-12-30 21:23
(18 d 09:04 ago)

@ Helmut
Posting: # 22163
Views: 342
 

 no luck so far...

Dear Helmut,

if you still want to find it by yourself, try this one

I opened the site and some links from there. But some links did not work for me, sometimes when I tried to download the docs, there were some messages that Adobe Flash Player is required (what??)
So the best way would be to wait for a native speaker...

Kind regards,
Mittyri
0521
☆    

China,
2021-01-04 07:31
(13 d 22:56 ago)

@ Helmut
Posting: # 22165
Views: 247
 

 Chinese BE GL

» does anybody know where to find the current GL of the Centre of Drug Evaluation? Google-translate gives up at http://www.cde.org.cn/.

Maybe I can help you.
But can you first clarify the acronym for "GL"?
Please try not to use any abbreviations, which makes it painful for non-native English speakers to understand.

"Guidance for Industry"?
"Guidelines"?

If it is "Guidelines", what kind of "Guidelines" do you want to get?
RSABE? ABE?


Maybe what you want is this:

Beijing time: December 31, 2020, public.

Chinese: 窄治疗指数药物生物等效性研究技术指导原则
English: Guidance for Industry: the study of drug bioequivalence with narrow therapeutic index

webpage:
http://www.cde.org.cn/zdyz.do?method=largePage&id=0a0af48eaf87d83b

PDF:
http://www.cde.org.cn/attachmentout.do?mothed=list&id=9ebc5d6ef23d5b97

技术指导原则=Guidance for Industry:


Edit: Posts merged. You can edit yor post for 24 hours. [Helmut]
Helmut
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Vienna, Austria,
2021-01-04 09:47
(13 d 20:40 ago)

@ 0521
Posting: # 22167
Views: 231
 

 HVD(P)s?

Hi 0521,

» But can you first clarify the acronym for "GL"?
» Please try not to use any abbreviations, which makes it painful for non-native English speakers to understand.

Sorry. In the future & if in doubt see the [image] Abbreviations on top of the page.

» "Guidance for Industry"?
» "Guidelines"?

Any would do.

» If it is "Guidelines", what kind of "Guidelines" do you want to get?
» RSABE? ABE?

Abbreviations, right? :-D
I was interested in the former but the latter would be fine as well.

» Maybe what you want is this: …

Almost! Seemingly it is for reference-scaling of narrow therapeutic index drugs. I’m looking for reference-scaling of highly variable drugs / drug products HVD(P)s.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
0521
☆    

China,
2021-01-04 11:10
(13 d 19:18 ago)

@ Helmut
Posting: # 22168
Views: 219
 

 HVD(P)s?

» In the future & if in doubt see the [image] Abbreviations on top of the page.

It looks great, maybe you can open up editing permissions to allow others to create comparison tables of words and descriptions in other languages.

"RSABE of highly variable drugs" is that.

Beijing time: October 29, 2018, public.

Chinese: 高变异药物生物等效性研究技术指导原则
English: Guidance for Industry: the study of drug bioequivalence with highly variable drugs

webpage:
http://www.cde.org.cn/zdyz.do?method=largePage&id=3fa6c1797e66be98

PDF:
http://www.cde.org.cn/attachmentout.do?mothed=list&id=caf29fdd9abce51e


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
Helmut
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Vienna, Austria,
2021-01-04 14:49
(13 d 15:39 ago)

@ 0521
Posting: # 22170
Views: 206
 

 China RSABE

Hi 0521,

» It looks great, maybe you can open up editing permissions to allow others to create comparison tables of words and descriptions in other languages.

Sorry, no way – we are already blocking more than 20 registration attempts by bots and script-kiddies per day. Hence, no write-permission for any file. The language of the site is (bad) English. :cool:

» "RSABE of highly variable drugs" is that.
»
» Beijing time: October 29, 2018, public.
»
» Chinese: 高变异药物生物等效性研究技术指导原则
» English: Guidance for Industry: the study of drug bioequivalence with highly variable drugs
»
» webpage:
» http://www.cde.org.cn/zdyz.do?method=largePage&id=3fa6c1797e66be98
»
» PDF:
» http://www.cde.org.cn/attachmentout.do?mothed=list&id=caf29fdd9abce51e

THX, again.

The site can’t be reached right now (I tried seven different browsers). Ping and traceroute timed out. Will try later.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Russia,
2021-01-04 21:16
(13 d 09:11 ago)

@ Helmut
Posting: # 22171
Views: 170
 

 China DNS != Google DNS

Hi Helmut,

» The site can’t be reached right now (I tried seven different browsers). Ping and traceroute timed out. Will try later.

I bet you have some Google DNS under the hood, right?
Try Chinese railway: 114.114.114.114

BTW, see the mailbox!

Kind regards,
Mittyri
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