Hello sir Thankyou so much for making this video it very simplified and easy understanding vedio. I cordially requesting you to please make videos on all quality guidelines.
One of the best video series I have seen, very clear voice and clarity in sound, Clear animation, voice -coordination with the slide content, crisp clear explanation, voice modulation
After watching your video with examples it is very easy to understand about bracketing and matrixing sir. Explanation is simply superb. Expecting more and more videos like this.
Thank you so much.. this was so helpful. I was unable to understand both the topics however the concept is completely clear to me. Keep on posting videos.. thumbs up
For ANDA filing 6 months stability study in accelerated and long term for release batches to be shown satisfactory, as per specification. If it passes, you can file ANDA.
Thank you so much for this video. Could you explain the reason of not reduced at 12 Month by writing? I have a terrible english listening skill so please explain one more time.. (I'm sorry) And my second question is.. are the reduced design applied only long time stability test ? (Not accelerating test?) Finally, Are this designs only applied in stability test for new drug? How about case in on-going test? Thank you! :)
Thank you so much for video. Very helpful. I have have a question about where bracketing and matrixing cannot be applied?? please let me know. Thanks in advance.
Akash g You are truly welcome. In following three scenarios don’t apply B&M #1 B& M should not be applied when different excipients are used among strengths. #2 B&M should not be performed across the test attributes. #3 B& M should not be applied If the your product’s test results shows large variability. Happy learning ....✍🏻
Please provide an explanation of the other example mentioned in the ICH Q1D guideline in the table 3a and 3b. How are T1, T2, and T3 is written? They are neither one-half nor one-third.
Matrixing does not have one half or one third reduction in testing. The requisite is - the testing should be done in such a way that all the variations (fill volume/container sizes, pack styles, strengths along with the time points) are covered. For example, if there are 10 strengths and four different pack styles, then any 4 batches per time point can be tested such that all pack styles/configurations are covered. Coming to the terminology used in the table 3a, 3b - replace T1, T2, T3 with respective batch numbers and you can understand it even better. Difference between matrixing and bracketing is - in bracketing, only the extremes are charged into stability studies and all the samples are analyzed, and in the matrixing design all the samples have to be charged into stability studies while the sample testing is done randomly that meets all the requirements.
"For the study of drug substances, matrixing is of limited utility and bracketing is generally not applicable" - this is what is mentioned in the guideline for API/drug substance. So bracketing is not applicable unless there is a sound scientific knowledge backing it. However, batch size of the API is not a parameter considered here. It is the fill/pack size that can be considered. NOTE: One tonne of API would be packed in 'n' number of smaller containers and not as the one tonne container. So the size of the API might not fit in this argument.
i really appreciate your efforts but i dislike it because of the background sound which is so irritating. my advise to you will be never put background sound in educational videos.
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Hello sir Thankyou so much for making this video it very simplified and easy understanding vedio. I cordially requesting you to please make videos on all quality guidelines.
One of the best video series I have seen, very clear voice and clarity in sound, Clear animation, voice -coordination with the slide content, crisp clear explanation, voice modulation
Shaandaar
Superbbbb
Very rare today not to ask to subscribe to the channel at the end of the video. Quite informative, i regularly watch this channel.
thanks Ashwani Sharma sir 🙏
Good bro! Keep spreading the knowledge.
The way of understanding guidelines is very good.keep it up sir
I could only say WOW.
After watching your video with examples it is very easy to understand about bracketing and matrixing sir. Explanation is simply superb. Expecting more and more videos like this.
Glad to hear that
Thank you so much it helped me alot.
Glad it helped!
very useful information.
You abd Pharma Group are my best channales to learn . thank you so much
Thanks and welcome
Very useful
Thank you so much.. this was so helpful. I was unable to understand both the topics however the concept is completely clear to me. Keep on posting videos.. thumbs up
Glad it was helpful!
Nice explanation. Thanks for this video.
Radha Krishna sir welcome 🙏🏼
Excellent
Very nicely explained
Thanks for this video..👍🤘❤
Crystal clear presentation 🙌👏
Glad it was helpful!
thanks for the video, good explanation
Great work👍
very nice explanation
Thanks and welcome
Thanks for the information.
Thanks a lot for giving us it information
👍👍👍👍👍
Thank you I read but not understand
Watch your video I completely understand
Thanks Yogesh
Best
Thanks for easy explanation.
Thank u sirji
This is really helpful... thanks a lot.
Glad it was helpful!
For ANDA filing 6 months stability study in accelerated and long term for release batches to be shown satisfactory, as per specification. If it passes, you can file ANDA.
Good
Very good video
Good..Nice video...pl.make on elemental impurities..tq...
Ok sure
Nice and informative
Very helpful..thanks
Thank you
Thank you very much. simplify the explanation, super.
Glad it was helpful!
@@PharmaPill expect the same on analytical method validation detail explanation.
Thanks alot bro... Please share information abt flow from drug discovery to final Formulation product... Process briefly
Nice information
Thanks
Can you make video on hplc detectors ,how to select detctors
Thank you sir👍
Pharma pill if the drug is dose proportional then bracketing & metricsing is applicable or not.
Thank you so much for this video. Could you explain the reason of not reduced at 12 Month by writing? I have a terrible english listening skill so please explain one more time.. (I'm sorry)
And my second question is.. are the reduced design applied only long time stability test ? (Not accelerating test?)
Finally, Are this designs only applied in stability test for new drug? How about case in on-going test?
Thank you! :)
THank you for the knowledge sharing. No background music please
In case of API how to define bracketing and Matrix ingredients?
Thank you so much for video. Very helpful. I have have a question about where bracketing and matrixing cannot be applied?? please let me know. Thanks in advance.
Akash g You are truly welcome. In following three scenarios don’t apply B&M
#1
B& M should not be applied when different excipients are used among strengths.
#2
B&M should not be performed across the test attributes.
#3
B& M should not be applied If the your product’s test results shows large variability.
Happy learning ....✍🏻
Superb explanation sir
Thanks and welcome
may I ask something, what is exactly the meaning of "strength" of a product?? great video btw
Strength is the amount of drug in a given dosage form.
@@PharmaPill thank you so much
Good explanation
Sandra Jackson thanku sir
Thank you. Well explained
Glad it was helpful!
Orey Gandham
Very good explanation brooo
Thank you so much 🙂
pls share video on ICH Q3A
Good information
Thanks
Superb video
rashmin patel 🙏🏼 happy learning
Plz made video on other guidelines ..this is best easiest way u teach bracketing and matrixing
rashmin patel noted 😊
What is placebo
Please provide an explanation of the other example mentioned in the ICH Q1D guideline in the table 3a and 3b. How are T1, T2, and T3 is written? They are neither one-half nor one-third.
Matrixing does not have one half or one third reduction in testing. The requisite is - the testing should be done in such a way that all the variations (fill volume/container sizes, pack styles, strengths along with the time points) are covered. For example, if there are 10 strengths and four different pack styles, then any 4 batches per time point can be tested such that all pack styles/configurations are covered. Coming to the terminology used in the table 3a, 3b - replace T1, T2, T3 with respective batch numbers and you can understand it even better. Difference between matrixing and bracketing is - in bracketing, only the extremes are charged into stability studies and all the samples are analyzed, and in the matrixing design all the samples have to be charged into stability studies while the sample testing is done randomly that meets all the requirements.
Background music???
Thax you so much sir for this video
Sir please next topic 21CFR
I have some doubt this bracketing is applicable for drug substances (API) FOR different batch sizes of the API. Pls answer sir thanks you in advnace
"For the study of drug substances, matrixing is of limited utility and bracketing is generally not applicable" - this is what is mentioned in the guideline for API/drug substance. So bracketing is not applicable unless there is a sound scientific knowledge backing it. However, batch size of the API is not a parameter considered here. It is the fill/pack size that can be considered.
NOTE: One tonne of API would be packed in 'n' number of smaller containers and not as the one tonne container. So the size of the API might not fit in this argument.
When to apply 1/2 and when to apply 1/3 reduction...?
It’s upto you whichever you want to follow
Brother we don't found oos part 2 video in you tube plz upload it
We are waiting
shankar Suri okay
Phitostability testing
Sir please dont put the music in it its so disturbing.
i really appreciate your efforts but i dislike it because of the background sound which is so irritating. my advise to you will be never put background sound in educational videos.
Sorry for that.. nowadays I am not doing… This video was prepared during my initial days…
Sorry but please work on English please don't mind .I have no bad intentions. And please add some visual facts .I Appreciate your work.
Nayab Singh Constructive criticism is always welcome.
Reduce background voice
your background music and english...pain
Even I do feel exactly 😊