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Back to the forum  Query: 2017-12-13 15:59 CET (UTC+1h)
 
javier
Junior

Spain,
2016-08-26 14:51

Posting: # 16587
Views: 3,556
 

 online BE course? [Conferences / Workshops]

Hi everyone

This is my first post, (so please forget the mistakes :) )

Im wonder if there is an online course aboute bioequivalence due to the huge amount of knowledge of several categories you need to master it

Could you kindly tell me if anyone know some interestings news about it?

kinds regadrs!

Javier Fdez

Clinical Pharmacologist
Hospital Universitario Puerta de Hierro, Spain
Helmut
Hero
Homepage
Vienna, Austria,
2016-08-26 15:38

@ javier
Posting: # 16588
Views: 3,001
 

 Basics and beyond…

¡Hola Javier!

» This is my first post, (so please forget the mistakes :) )

Welcome to the club! We learn only from mistakes. ;-)

» Im wonder if there is an online course aboute bioequivalence due to the huge amount of knowledge of several categories you need to master it

I don’t know of any. For the basics see “A First Course in Pharmacokinetics and Biopharmaceutics” by David Bourne. Consider diving into my presentations.

[image]Regards,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
BE-proff
Senior

Russia,
2016-08-26 20:01

@ Helmut
Posting: # 16595
Views: 2,939
 

 Basics and beyond…

Privet Helmut,

It's high time for you to write a manual for bioequivalence in several volumes :-D
Don't loose the time! :-D
Helmut
Hero
Homepage
Vienna, Austria,
2016-08-26 20:32

@ BE-proff
Posting: # 16596
Views: 2,976
 

 Basics and beyond…

привет BE-proff!

» It's high time for you to write a manual for bioequivalence in several volumes :-D

Oh no! I once even had a contract with Wiley to co-author a book on the topic – which for unknown reasons is still listed at Amazon India. I withdraw after a year without having more than the headings of the chapters. Not my thing.

» Don't loose the time! :-D

Maybe once I’ve retired. Extremely unlikely.

[image]Regards,
Helmut Schütz 
[image]

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

Spain,
2016-08-26 21:33

@ Helmut
Posting: # 16598
Views: 2,931
 

 Basics and beyond…

Hi Helmut

Thanks for the info, i've to say you've built an amazing webpage, i can't imagine how much time you've invested it, taking for example the guideline page, i hope i would assist one of your lectures in a future congress, meanwhile i'll take your advise and follow the links

Auf Wiedersehen!

Javier
Clinical Pharmacologist


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]
ElMaestro
Hero

Denmark,
2016-08-26 22:25

@ javier
Posting: # 16599
Views: 2,951
 

 online BE course?

Hi javier,

» This is my first post, (so please forget the mistakes :) )

Great you signed up :-) There is a first time for everything.


» Im wonder if there is an online course aboute bioequivalence (...)

I am reasonably well connected to regulatory bodies like EMA, NMAs, WHO, as well as people at USP, EDQM and a range of conference organizers.
I have suggested a million times that courses focusing on BE be available online or as targeted training. All people I talk to seem to like the idea very much. And all people I talk seem to believe someone else should be taking the action.

I have attended events focusing on BE and provided by people who came from the innovator side. They are generally disastrously bad. Innovator people are not humble, and the attitude is that if you know about innovator drugs then you know everything abuot BE because BE is just a quick and dirty type of innovator thinking. It is sometimes abysmal. I recall an event associated with the main AAPS confy in San Antonio 2013 where the guys at the panel tried to define BE universally but were oblivious to the fact that BE is not the same in EU as it is in US. And in stead of just admitting they had overlooked a detail which in the grand scheme of things is extremely important and a game-changer in terms of study types (PK vs PD) they were just clueless. I had to snort a tripple dose of my preferred tranquilizer "Crystal Schütz" that day.
Anyways, I can work with BE for 100 years without ever becoming a master of any degree. That is a positive challenge, too. I enjoy it.:-)

So you are right. We need training of all sorts, incl. online. It should be provided by the right people. If it isn't it will just not work.

In case you happen to be a regulator by some definition or other there may be opportunities for you in the not too distant future. In that case message me privately via the forum's mail function.

I could be wrong, but…


Best regards,
ElMaestro

A potentially biased estimator may be a relevant estimator. The case of REML speaks volumes.
javier
Junior

Spain,
2016-09-14 15:58

@ ElMaestro
Posting: # 16636
Views: 2,406
 

 online BE course?

» I have suggested a million times that courses focusing on BE be available online or as targeted training. All people I talk to seem to like the idea very much. And all people I talk seem to believe someone else should be taking the action.

I couldnt more agree with you. This is the typical behaviour when someone try to solve a problem, no matter the subject

(Sorry for the delayed answer but I broke my knee, and i have been a little busy with surgery and rehabs)
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