Ohlbe
★★★

France,
2019-03-03 22:18

Posting: # 19994
Views: 1,370

## Draft ICH M10 published [Regulatives / Guidelines]

Dear all,

The draft ICH M10 guideline on bioanalytical method validation has been published for consultation.

It will be heavily discussed at the next WRIB and EBF meetings.

Regards
Ohlbe
Helmut
★★★

Vienna, Austria,
2019-03-04 00:08

@ Ohlbe
Posting: # 19995
Views: 1,282

## Consultation period?

THX, Ohlbe!

Based on the consultation periods of M9 one can only speculate:

Singapore         2nd week of July Taiwan            3rd week of July Canada            4th week of July China             3rd week of August Korea             3rd week of September Brazil            2nd week of October Japan             3rd week of October EEA, Switzerland  4th week of October USA               ?

Cheers,
Helmut Schütz

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

France,
2019-03-14 22:16

@ Helmut
Posting: # 20035
Views: 993

## EU/EEA

Dear Helmut,

» Based on the consultation periods of M9 one can only speculate:
»

EEA, Switzerland  4th week of October

Actually shorter than that in the EU/EEA: 1st September.

Regards
Ohlbe
wienui
★

Germany, Oman,
2019-03-13 17:06

@ Ohlbe
Posting: # 20023
Views: 1,118

## ICH M10 draft

Dear all,

"New or Alternative Technologies" an interesting part in the newly issued draft of BIOANALYTICAL METHOD VALIDATION, ICH M10 which Endorsed on 26 February 2019.

- When a new or alternative technology is used as the sole bioanalytical technology from the onset of drug development, cross-validation with an existing technology is not required.
Cross-validation but required when using two different bioanalytical technologies for the development of a drug.

on the other hand, The use of two methods or technologies within a
comparative BA/BE study is strongly discouraged:. (i.e not applicable at all also with cross-validation).
Why ??

Best regards,
Osama

Edit: Post moved. [Helmut]
Ohlbe
★★★

France,
2019-03-13 17:21

@ wienui
Posting: # 20025
Views: 1,117

## Multiple methods within a single trial

Dear Osama,

» on the other hand, The use of two methods or technologies within a
» comparative BA/BE study is strongly discouraged:. (i.e not applicable at all also with cross-validation).
» Why ??

I would reverse the question: why would you use two different methods, or two different technologies, within a single BE trial, with the risk of increasing variability ? We're not talking of 2 different trials here (where one can be done at one CRO and the other at another CRO, with a different method).

Regards
Ohlbe
wienui
★

Germany, Oman,
2019-03-13 17:44

@ Ohlbe
Posting: # 20027
Views: 1,096

## Multiple methods within a single trial

Dear Ohlbe,

» I would reverse the question: why would you use two different methods, or two different technologies, within a single BE trial, with the risk of increasing variability? We're not talking of 2 different trials here (where one can be done at one CRO and the other at another CRO, with a different method).

Please think about very big clinical trials which required a multi-centers ( e.g for Anti-cancer drugs), you deal here with different CRO's which could have different technologies.

Best regards,
Osama
Ohlbe
★★★

France,
2019-03-13 18:10

@ wienui
Posting: # 20029
Views: 1,070

## Multiple methods within a single trial

Dear Osama,

» Please think about very big clinical trials which required a multi-centers ( e.g for Anti-cancer drugs), you deal here with different CRO's which could have different technologies.

BE trials in patients are indeed usually multi-centre trials. But multiple clinical sites does not mean there has to be multiple bioanalytical labs (unless the analyte is so unstable the samples cannot even afford to be shipped to a central lab ? I don't have any practical example in mind).

The one difficulty could be if due to the study duration the lab closes down half-way through the study and a new lab has to be used.

Regards
Ohlbe
wienui
★

Germany, Oman,
2019-03-13 18:35

@ Ohlbe
Posting: # 20030
Views: 1,075

## Multiple methods within a single trial

Dear Ohlbe,

» BE trials in patients are indeed usually multi-centre trials. But multiple clinical sites does not mean there has to be multiple bioanalytical labs (unless the analyte is so unstable the samples cannot even afford to be shipped to a central lab ? I don't have any practical example in mind).
»
» The one difficulty could be if due to the study duration the lab closes down half-way through the study and a new lab has to be used.

Such multiple clinical trial centers ( for one drug product), you might find them in different cities, ( you could find them even in different countries depending on the presence of the patients for a certain disease, therefore we will not be able to talk about a central lab, which uses the same technology.

I have already dealt with such study conducted for an anti-cancer drug in different CRO's in different cities.

Best regards,
Osama
Ohlbe
★★★

France,
2019-03-13 22:01

@ wienui
Posting: # 20031
Views: 1,054

## Multiple methods within a single trial

Dear Osama,

» I have already dealt with such study conducted for an anti-cancer drug in different CRO's in different cities.

Well, I've seen a few too, and all used a single, central bioanalytical lab...

It is true that it requires some logistics: local processing and storage of the samples, delivery of dry ice, pick-up of the samples by specialised transporters etc. All this does have a cost. On the other hand, you save on the development and validation of a bioanalytical method at each local laboratory. Plus the audit of each lab and QC of what they do. And an increased variability means a loss of power, thus additional patients needed.

CROs involved in this type of studies usually have a network of clinical sites with which they are used to working. They take care of all the logistics. If not: find another... It's worth it.

Regards
Ohlbe
Helmut
★★★

Vienna, Austria,
2019-03-13 17:23

@ wienui
Posting: # 20026
Views: 1,109

## one study, one method

Salam Osama,

» […] The use of two methods or technologies within a
» comparative BA/BE study is strongly discouraged:. ( i.e not applicable at all also with cross-validation).
» Why ??

Honestly, I would not feel comfortable with such an approach as well. Even if two methods are fully validated and cross-validated against each other. Though, at least in a crossover it should be OK.
I faced very few examples that a validated method (you know, only spiked samples…) turned out to perform “not so good” on real samples. In these cases we developed another method and re-analysed all samples with the new method. I cannot imagine a situation when someone would change a suitable method within a study just for fun.

Cheers,
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Bioequivalence and Bioavailability Forum |  Admin contact
19,576 posts in 4,154 threads, 1,340 registered users;
online 11 (0 registered, 11 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 13:50 UTC

Science may set limits to knowledge,
but should not set limits to imagination.    Bertrand Russell

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
Ing. Helmut Schütz