Sitter på urtråkig läkemdelstillverkningskonferens så jag passar på att svara på stabilitetsfrågan.
1. När ett nytt lm utvecklas är det jättebråttom och man försöker få med så mycket och långa stabilitetsdata som det bara går. Hur det skall ske regleras av ett dokument som heter ICH Q1(A-F).
2. När man fått ut sin produkt på marknaden måste man ha ett stabilitetsprogram under produktens livstid. Finns också reglerat på samma ställe.
Det man testar är att lm håller sig inom sin produktspecifikation under den angivna hållbarhetstiden, t ex inte bryts ned mer än 5% från nominell dos (om det är den spridning som tillåts i produktspecen.)
3. Om man skall förlänga sin hållbarhetstid måste man skicka in en variation till myndigheterna. Det kräver ganska mycket dokumentation och ökar såklart rsiken att hamna utanför spec och tvingas återkalla produkter. Om man ändå säljer och tjänar pengar krävs det nog ett ganska bra ekonomiskt skäl till en sådan ändring.
Kontentan är att de flesta lm, om de förvarats på det sätt de skall, troligen kan användas långt efter det att bäst-före-datumet går ut. Det som troligast händer är att det bara finns lite mindre aktiv substans i dem än det står på etiketten.
Kan de bli giftiga? Troligen inte. Om de utsätts för en felaktig miljö (hög värme eller någon gas eller något sådant, kan det hända att en substans reagerar eller bryts ned till en annan substans, men vilken det skulle bli och vilka effekter en sådan skulle få på kroppen är nästan omöjligt att förutsäga. Det kan man bara spekulera i. Det finns några vandringslegender, men det är tveksamt om de är sanna.)
Det var lite snabbt. Någon annan kanske vet mer 🙂
/Magnus
Kanske skall tillägga att jag inte rekommenderar någon att strunta i bäst-före-datum 😉 Man måste ha bra koll på terapeutiska fönster, nedbrytningshastighet osv för att ta risken. Insulin, t.ex skall man inte gambla med. Det bryts ned snabbt och konsekvenserna av att ta lågpotent insulin kan vara fatala …
/Magnus
Hejsan!
Började lystna på er podcast igår, och har redan plöjt igenom runt tio avsnitt. Jättebra och intressant podcast!
Jag har länge velat bli läkare och har sökt samtliga utbildningar i Sverige (och PIL) till våren. Skulle inte ni kunna prata lite om hur det var att studera till läkare på er tid?
I’m impressed, I have to admit. Rarely do I come across a blog that’s equally
educative and amusing, and without a doubt, you
have hit the nail on the head. The problem is an issue that too few folks are speaking intelligently about.
I’m very happy that I found this in my hunt for something concerning this.
Hey just wanted to give you a quick heads up.
The text in your article seem to be running off the screen in Ie.
I’m not sure if this is a formatting issue or something to do with browser compatibility but I figured I’d post to let you know.
The design look great though! Hope you get
the problem fixed soon. Thanks
You could certainly see your enthusiasm within the article
you write. The sector hopes for even more passionate writers such as you who are not afraid to mention how they believe.
All the time go after your heart.
Thank you a bunch for sharing this with all people you really recognise what you are
speaking about! Bookmarked. Please also visit
my site =). We may have a link exchange arrangement between us
Nice post. I was checking continuously this blog and I am impressed!
Very useful information particularly the last part 🙂 I care
for such info a lot. I was seeking this certain info for a very long
time. Thank you and best of luck.
A person necessarily lend a hand to make severely articles I’d state.
That is the first time I frequented your website page and so far?
I amazed with the research you made to create this actual publish
extraordinary. Magnificent activity!
Excellent website. Lots of useful information here.
I am sending it to a few friends ans additionally sharing in delicious.
And of course, thank you for your effort!
Hey there! Do you know if they make any plugins to help with
Search Engine Optimization? I’m trying to get my blog
to rank for some targeted keywords but I’m not seeing very good results.
If you know of any please share. Kudos!
It’s a shame you don’t have a donate button! I’d most certainly donate to this outstanding blog!
I suppose for now i’ll settle for bookmarking and adding your RSS feed to my
Google account. I look forward to fresh updates and will talk about this website with my Facebook group.
Talk soon!
I needed to thank you for this fantastic read!! I absolutely enjoyed every little bit of it.
I have got you book marked to look at new things you post…
You actually make it seem really easy together with
your presentation however I in finding this topic to be actually something which I believe I would never understand.
It sort of feels too complicated and very huge for me.
I’m taking a look forward for your next put up, I will attempt to get the grasp
of it!
Oh my goodness! Impressive article dude! Thank you so much, However I am encountering
troubles with your RSS. I don’t understand why I cannot join it.
Is there anybody else getting similar RSS problems? Anyone who
knows the solution will you kindly respond? Thanks!!
Hello! Would you mind if I share your blog with my myspace group?
There’s a lot of folks that I think would really appreciate your content.
Please let me know. Thanks
I absolutely love your site.. Very nice colors & theme.
Did you build this amazing site yourself? Please reply back as I’m hoping to create my own website and would like to know where you got this from or what the theme is
called. Thank you!
Wonderful goods from you, man. I have understand your stuff previous to
and you are just extremely magnificent. I really
like what you have acquired here, really like what you are stating and the way in which you say it.
You make it enjoyable and you still take care of to keep it sensible.
I can’t wait to read far more from you. This is actually a tremendous website.
I loved as much as you will receive carried out right here.
The sketch is tasteful, your authored material stylish.
nonetheless, you command get bought an shakiness over that you
wish be delivering the following. unwell unquestionably come further formerly again as exactly the same nearly
very often inside case you shield this hike.
Howdy, i read your blog from time to time and i own a similar one and i was just
curious if you get a lot of spam comments? If so how do you protect
against it, any plugin or anything you can advise? I get so
much lately it’s driving me crazy so any help is very much appreciated.
I’m not sure exactly why but this weblog is
loading incredibly slow for me. Is anyone else having this
issue or is it a issue on my end? I’ll check back later and see if the problem still
exists.
great publish, very informative. I ponder why
the other specialists of this sector don’t notice this.
You must continue your writing. I’m confident, you’ve a huge readers’ base already!
I am not sure where you are getting your info, but good topic.
I needs to spend some time learning more or understanding more.
Thanks for fantastic information I was looking for
this info for my mission.
I was suggested this web site by my cousin. I am not sure whether this post is written by him as no one else know such detailed about my trouble.
You’re incredible! Thanks!
Thank you for the good writeup. It in reality used to be a leisure account it.
Look complicated to far added agreeable from you! However, how can we keep in touch?
I’ll right away seize your rss as I can not to find your email subscription link or newsletter
service. Do you’ve any? Please let me understand so that I could subscribe.
Thanks.
Hi there! This is kind of off topic but I need some help from
an established blog. Is it hard to set up your own blog?
I’m not very techincal but I can figure things out pretty quick.
I’m thinking about making my own but I’m not sure where to
start. Do you have any tips or suggestions?
you’re truly a good webmaster. The site loading speed is
incredible. It sort of feels that you are doing
any distinctive trick. Furthermore, The contents are masterpiece.
This is a really good tip especially to those fresh to the blogosphere.
Brief but very accurate information… Appreciate your sharing this
one. A must read post!
Fascinating blog! Is your theme custom made or did you download
it from somewhere? A theme like yours with a few simple tweeks would
really make my blog jump out. Please let me know where you
got your design. Thanks natalielise pof
Excellent blog! Do you have any suggestions for aspiring writers?
I’m planning to start my own blog soon but I’m a little lost on everything.
Would you propose starting with a free platform like WordPress or
go for a paid option? There are so many options out there that I’m totally confused ..
Any suggestions? Appreciate it!
Its like you read my mind! You appear to know so much about this,
like you wrote the book in it or something. I think that you could do with
a few pics to drive the message home a little bit, but other than that, this is excellent blog.
A fantastic read. I’ll definitely be back. natalielise pof
Woah! I’m really loving the template/theme of this
website. It’s simple, yet effective. A lot of times it’s tough to get that ”perfect balance” between superb usability and
visual appearance. I must say you’ve done a great job
with this. Additionally, the blog loads extremely fast for me on Firefox.
Excellent Blog!
Hey I know this is off topic but I was wondering if you knew of any widgets I could add to my
blog that automatically tweet my newest twitter updates.
I’ve been looking for a plug-in like this for quite some time and was
hoping maybe you would have some experience with something like this.
Please let me know if you run into anything. I truly enjoy reading your blog and I look forward to
your new updates.
Sitter på urtråkig läkemdelstillverkningskonferens så jag passar på att svara på stabilitetsfrågan.
1. När ett nytt lm utvecklas är det jättebråttom och man försöker få med så mycket och långa stabilitetsdata som det bara går. Hur det skall ske regleras av ett dokument som heter ICH Q1(A-F).
2. När man fått ut sin produkt på marknaden måste man ha ett stabilitetsprogram under produktens livstid. Finns också reglerat på samma ställe.
Det man testar är att lm håller sig inom sin produktspecifikation under den angivna hållbarhetstiden, t ex inte bryts ned mer än 5% från nominell dos (om det är den spridning som tillåts i produktspecen.)
3. Om man skall förlänga sin hållbarhetstid måste man skicka in en variation till myndigheterna. Det kräver ganska mycket dokumentation och ökar såklart rsiken att hamna utanför spec och tvingas återkalla produkter. Om man ändå säljer och tjänar pengar krävs det nog ett ganska bra ekonomiskt skäl till en sådan ändring.
Kontentan är att de flesta lm, om de förvarats på det sätt de skall, troligen kan användas långt efter det att bäst-före-datumet går ut. Det som troligast händer är att det bara finns lite mindre aktiv substans i dem än det står på etiketten.
Kan de bli giftiga? Troligen inte. Om de utsätts för en felaktig miljö (hög värme eller någon gas eller något sådant, kan det hända att en substans reagerar eller bryts ned till en annan substans, men vilken det skulle bli och vilka effekter en sådan skulle få på kroppen är nästan omöjligt att förutsäga. Det kan man bara spekulera i. Det finns några vandringslegender, men det är tveksamt om de är sanna.)
Det var lite snabbt. Någon annan kanske vet mer 🙂
/Magnus
Tusen tack Magnus för kanonbra svar. Vi kommer troligen återkoppla några av dem i nästa avsnitt!
/Christian
Kanske skall tillägga att jag inte rekommenderar någon att strunta i bäst-före-datum 😉 Man måste ha bra koll på terapeutiska fönster, nedbrytningshastighet osv för att ta risken. Insulin, t.ex skall man inte gambla med. Det bryts ned snabbt och konsekvenserna av att ta lågpotent insulin kan vara fatala …
/Magnus
Hejsan!
Började lystna på er podcast igår, och har redan plöjt igenom runt tio avsnitt. Jättebra och intressant podcast!
Jag har länge velat bli läkare och har sökt samtliga utbildningar i Sverige (och PIL) till våren. Skulle inte ni kunna prata lite om hur det var att studera till läkare på er tid?
Ciao
kul att du gillar. jo, bra tema. Tillbakablick kanske det får bli:)
/Christian
Fick tips om er podcast via en kollega, väldigt kul att lyssna på er måste jag säga. 🙂
Kul att du gillar! Vad jobbar du själv med?!
Jag studerar till rtgssk men jobbar extra på röntgen som uska.
I’m impressed, I have to admit. Rarely do I come across a blog that’s equally
educative and amusing, and without a doubt, you
have hit the nail on the head. The problem is an issue that too few folks are speaking intelligently about.
I’m very happy that I found this in my hunt for something concerning this.
Yes! Finally someone writes about minecraft.
What’s up to every body, it’s my first go to see of this webpage; this weblog includes amazing and really fine stuff in favor of readers.
Hey just wanted to give you a quick heads up.
The text in your article seem to be running off the screen in Ie.
I’m not sure if this is a formatting issue or something to do with browser compatibility but I figured I’d post to let you know.
The design look great though! Hope you get
the problem fixed soon. Thanks
Hello There. I found your blog using msn. This is an extremely well written article.
I will be sure to bookmark it and come back to read more of your useful information. Thanks for the post.
I’ll certainly comeback.
You could certainly see your enthusiasm within the article
you write. The sector hopes for even more passionate writers such as you who are not afraid to mention how they believe.
All the time go after your heart.
Thank you a bunch for sharing this with all people you really recognise what you are
speaking about! Bookmarked. Please also visit
my site =). We may have a link exchange arrangement between us
Nice post. I was checking continuously this blog and I am impressed!
Very useful information particularly the last part 🙂 I care
for such info a lot. I was seeking this certain info for a very long
time. Thank you and best of luck.
A person necessarily lend a hand to make severely articles I’d state.
That is the first time I frequented your website page and so far?
I amazed with the research you made to create this actual publish
extraordinary. Magnificent activity!
Excellent website. Lots of useful information here.
I am sending it to a few friends ans additionally sharing in delicious.
And of course, thank you for your effort!
I think the admin of this website is in fact working hard
in favor of his site, as here every stuff is quality based information.
You should be a part of a contest for one of the most useful
websites on the internet. I will recommend this blog!
Hey there! Do you know if they make any plugins to help with
Search Engine Optimization? I’m trying to get my blog
to rank for some targeted keywords but I’m not seeing very good results.
If you know of any please share. Kudos!
Hello, Neat post. There’s an issue along with your website in internet explorer, might test this?
IE nonetheless is the marketplace leader and a big component of people will leave out your fantastic writing because of this problem.
It’s a shame you don’t have a donate button! I’d most certainly donate to this outstanding blog!
I suppose for now i’ll settle for bookmarking and adding your RSS feed to my
Google account. I look forward to fresh updates and will talk about this website with my Facebook group.
Talk soon!
I needed to thank you for this fantastic read!! I absolutely enjoyed every little bit of it.
I have got you book marked to look at new things you post…
You actually make it seem really easy together with
your presentation however I in finding this topic to be actually something which I believe I would never understand.
It sort of feels too complicated and very huge for me.
I’m taking a look forward for your next put up, I will attempt to get the grasp
of it!
kuburan, dengan kamus di tangannya. link 9
agen astm a283 c
agen pipa boiler
agen plat abrex 400
agen plat asme516 grade70
agen plat astm a285 c
agen plat astm516 70
agen plat boiler
agen plat hardox
agen plat hb 400
agen plat high strenght
agen plat high tensile sm490 yb
agen plat high tensile sm490ya
agen plat kapal
agen plat stainless ss304
agen plat stainless ss310
agen plat stainless ss316
agen plat sumihard
agen round bar besi aisi 440s45c
agen round bar scm440
agen steel rail
agen steel sheet pile
distributor astm a283 c
distributor pipa boiler
distributor plat abrex 400
distributor plat asme516 grade70
distributor plat astm a285 c
distributor plat astm516 70
distributor plat boiler
distributor plat hb 400
distributor plat high strenght
distributor plat high tensile sm490 yb
distributor plat high tensile sm490ya
distributor plat kapal
distributor plat stainless ss304
distributor plat stainless ss310
distributor plat stainless ss316
distributor plat sumihard
distributor round bar besi aisi 440s45c
distributor round bar scm440
distributor steel rail
distributor steel sheet pile
jual astm a283 c
jual baja h beam
jual pipa boiler
jual plat abrex 400
jual plat asme516 grade70
jual plat astm a285 c
jual plat astm516 70
jual plat boiler
jual plat hardox
jual plat hb 400
jual plat high strenght
jual plat high tensile sm490 yb
jual plat high tensile sm490ya
jual plat kapal
jual plat stainless ss304
jual plat stainless ss310
jual plat stainless ss316
jual plat sumihard
jual round bar besi aisi 440s45c
jual round bar scm440
jual steel rail
jual steel sheet pile
pabrik astm a283 c
pabrik pipa boiler
pabrik plat abrex 400
pabrik plat asme516 grade70
pabrik plat astm516 70
pabrik plat boiler
pabrik plat hb 400
pabrik plat high tensile sm490 yb
pabrik plat high tensile sm490ya
pabrik plat kapal
pabrik plat stainless ss304
pabrik plat stainless ss310
pabrik round bar besi aisi 440s45c
pabrik round bar scm440
pabrik steel rail
pabrik steel sheet pile
pusat astm a283 c
pusat pipa boiler
pusat plat abrex 400
pusat plat asme516 grade70
pusat plat astm a285 c
pusat plat astm516 70
pusat plat boiler
pusat plat hardox
pusat plat hb 400
pusat plat high strenght
pusat plat high tensile sm490 yb
pusat plat high tensile sm490ya
pusat plat kapal
pusat plat stainless ss304
pusat plat stainless ss310
pusat plat stainless ss316
pusat plat sumihard
pusat round bar besi aisi 440s45c
pusat round bar scm440
pusat steel rail
pusat steel sheet pile
stockis plat hardox
stockist plat astm a285 c
stockist plat high strenght
stockist plat stainless ss316
stockist plat sumihard
supplier plat hardox
plat stainless ss201
plat sphc po
plat putih spcc sd
plat hitam ss400
plat hitam sphc
plat corten
plat astm a36
plat alumunium
plat abrex 500
plat abrex 450
plain bar
pipa sch80
pipa sch40
pipa sch160
pipa sch120
pipa sch10
pipa medium galvanis
perforated plate
grating size galvanis
expanded metal
deformed bar
besi wiremesh
besi unp
besi cnp
besi baja wfbeam
baja h beam
Oh my goodness! Impressive article dude! Thank you so much, However I am encountering
troubles with your RSS. I don’t understand why I cannot join it.
Is there anybody else getting similar RSS problems? Anyone who
knows the solution will you kindly respond? Thanks!!
Hello! Would you mind if I share your blog with my myspace group?
There’s a lot of folks that I think would really appreciate your content.
Please let me know. Thanks
It’s nearly impossible to find educated people on this subject,
however, you seem like you know what you’re talking about!
Thanks
It’s awesome designed for me to have a web page,
which is good for my know-how. thanks admin
Informative article, just what I was looking for.
There’s certainly a lot to learn about this subject. I love all the points you’ve made.
I absolutely love your site.. Very nice colors & theme.
Did you build this amazing site yourself? Please reply back as I’m hoping to create my own website and would like to know where you got this from or what the theme is
called. Thank you!
That is a great tip especially to those new to the blogosphere.
Brief but very accurate information… Appreciate your sharing this one.
A must read post!
Wonderful goods from you, man. I have understand your stuff previous to
and you are just extremely magnificent. I really
like what you have acquired here, really like what you are stating and the way in which you say it.
You make it enjoyable and you still take care of to keep it sensible.
I can’t wait to read far more from you. This is actually a tremendous website.
I loved as much as you will receive carried out right here.
The sketch is tasteful, your authored material stylish.
nonetheless, you command get bought an shakiness over that you
wish be delivering the following. unwell unquestionably come further formerly again as exactly the same nearly
very often inside case you shield this hike.
Howdy, i read your blog from time to time and i own a similar one and i was just
curious if you get a lot of spam comments? If so how do you protect
against it, any plugin or anything you can advise? I get so
much lately it’s driving me crazy so any help is very much appreciated.
Quality posts is the crucial to interest the people to go to
see the web site, that’s what this web page is providing.
What’s up, I read your new stuff daily. Your humoristic
style is witty, keep it up!
I’m not sure exactly why but this weblog is
loading incredibly slow for me. Is anyone else having this
issue or is it a issue on my end? I’ll check back later and see if the problem still
exists.
Every weekend i used to go to see this site, because i wish for enjoyment, for the reason that
this this website conations really nice funny data too.
great publish, very informative. I ponder why
the other specialists of this sector don’t notice this.
You must continue your writing. I’m confident, you’ve a huge readers’ base already!
I am not sure where you are getting your info, but good topic.
I needs to spend some time learning more or understanding more.
Thanks for fantastic information I was looking for
this info for my mission.
I needed to thank you for this great read!! I definitely enjoyed every little bit
of it. I have you bookmarked to look at new things you post…
I was suggested this web site by my cousin. I am not sure whether this post is written by him as no one else know such detailed about my trouble.
You’re incredible! Thanks!
Thank you for the good writeup. It in reality used to be a leisure account it.
Look complicated to far added agreeable from you! However, how can we keep in touch?
I could not resist commenting. Very well written!
Great article.
This is a topic that is close to my heart… Thank you!
Where are your contact details though?
I’m extremely impressed with your writing skills and also with the layout on your weblog.
Is this a paid theme or did you modify it yourself?
Anyway keep up the nice quality writing, it is rare to see a great blog like this
one nowadays.
Hello, I enjoy reading all of your article. I like to write
a little comment to support you.
I’ll right away seize your rss as I can not to find your email subscription link or newsletter
service. Do you’ve any? Please let me understand so that I could subscribe.
Thanks.
Hi there! This is kind of off topic but I need some help from
an established blog. Is it hard to set up your own blog?
I’m not very techincal but I can figure things out pretty quick.
I’m thinking about making my own but I’m not sure where to
start. Do you have any tips or suggestions?
Cheers
Yes! Finally something about plenty of fish dating
site.
you’re truly a good webmaster. The site loading speed is
incredible. It sort of feels that you are doing
any distinctive trick. Furthermore, The contents are masterpiece.
you’ve done a excellent job on this subject!
Hello friends, good piece of writing and good arguments commented here,
I am in fact enjoying by these.
This is a really good tip especially to those fresh to the blogosphere.
Brief but very accurate information… Appreciate your sharing this
one. A must read post!
What’s up to all, the contents present at this
site are genuinely remarkable for people knowledge, well, keep
up the nice work fellows.
Fascinating blog! Is your theme custom made or did you download
it from somewhere? A theme like yours with a few simple tweeks would
really make my blog jump out. Please let me know where you
got your design. Thanks natalielise pof
Awesome! Its genuinely awesome piece of writing, I have
got much clear idea about from this paragraph.
Oh my goodness! Incredible article dude! Thanks, However I
am encountering difficulties with your RSS. I don’t understand why I can’t join it.
Is there anybody having identical RSS problems?
Anyone that knows the answer will you kindly respond?
Thanks!!
Great delivery. Solid arguments. Keep up the good work.
Excellent blog! Do you have any suggestions for aspiring writers?
I’m planning to start my own blog soon but I’m a little lost on everything.
Would you propose starting with a free platform like WordPress or
go for a paid option? There are so many options out there that I’m totally confused ..
Any suggestions? Appreciate it!
Ridiculous quest there. What occurred after? Take care!
Its like you read my mind! You appear to know so much about this,
like you wrote the book in it or something. I think that you could do with
a few pics to drive the message home a little bit, but other than that, this is excellent blog.
A fantastic read. I’ll definitely be back. natalielise pof
Woah! I’m really loving the template/theme of this
website. It’s simple, yet effective. A lot of times it’s tough to get that ”perfect balance” between superb usability and
visual appearance. I must say you’ve done a great job
with this. Additionally, the blog loads extremely fast for me on Firefox.
Excellent Blog!
Hey I know this is off topic but I was wondering if you knew of any widgets I could add to my
blog that automatically tweet my newest twitter updates.
I’ve been looking for a plug-in like this for quite some time and was
hoping maybe you would have some experience with something like this.
Please let me know if you run into anything. I truly enjoy reading your blog and I look forward to
your new updates.
Amazing issues here. I’m very glad to see your article.
Thank you so much and I’m taking a look forward to touch you.
Will you please drop me a mail?
I know this website offers quality depending articles or
reviews and extra stuff, is there any other site which presents these
data in quality?
What a stuff of un-ambiguity and preserveness of valuable familiarity
regarding unpredicted emotions.