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

Very rare today not to ask to subscribe to the channel at the end of the video. Quite informative, i regularly watch this channel.

@PharmaPill

Жыл бұрын

thanks Ashwani Sharma sir 🙏

Good bro! Keep spreading the knowledge.

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.

@PharmaPill

2 жыл бұрын

Glad to hear that

You abd Pharma Group are my best channales to learn . thank you so much

@PharmaPill

Жыл бұрын

Thanks and welcome

Thank you so much it helped me alot.

@PharmaPill

Жыл бұрын

Glad it helped!

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

@PharmaPill

2 жыл бұрын

Glad it was helpful!

The way of understanding guidelines is very good.keep it up sir

Thanks for this video..👍🤘❤

thanks for the video, good explanation

Nice explanation. Thanks for this video.

@PharmaPill

5 жыл бұрын

Radha Krishna sir welcome 🙏🏼

Thanks for the information.

Thanks a lot for giving us it information

Crystal clear presentation 🙌👏

@PharmaPill

2 жыл бұрын

Glad it was helpful!

I could only say WOW.

Shaandaar

Great work👍

Thank you I read but not understand Watch your video I completely understand

@PharmaPill

2 жыл бұрын

Thanks Yogesh

Superbbbb

This is really helpful... thanks a lot.

@PharmaPill

3 жыл бұрын

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.

Thanks for easy explanation.

Very nicely explained

very useful information.

Can you make video on hplc detectors ,how to select detctors

Thank you

Very helpful..thanks

Excellent

Good..Nice video...pl.make on elemental impurities..tq...

@PharmaPill

4 жыл бұрын

Ok sure

Pharma pill if the drug is dose proportional then bracketing & metricsing is applicable or not.

Thanks alot bro... Please share information abt flow from drug discovery to final Formulation product... Process briefly

very nice explanation

@PharmaPill

2 жыл бұрын

Thanks and welcome

Very useful

Thank you very much. simplify the explanation, super.

@PharmaPill

Жыл бұрын

Glad it was helpful!

@arunhg8234

Жыл бұрын

@@PharmaPill expect the same on analytical method validation detail explanation.

Thank u sirji

👍👍👍👍👍

In case of API how to define bracketing and Matrix ingredients?

Thank you sir👍

Very good video

Best

Nice and informative

What is placebo

pls share video on ICH Q3A

Good

Thank you. Well explained

@PharmaPill

3 жыл бұрын

Glad it was helpful!

@EducationEuphoria

6 ай бұрын

Orey Gandham

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.

@PharmaPill

5 жыл бұрын

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 ....✍🏻

THank you for the knowledge sharing. No background music please

Nice information

@PharmaPill

3 жыл бұрын

Thanks

Superb explanation sir

@PharmaPill

3 жыл бұрын

Thanks and welcome

Good explanation

@PharmaPill

5 жыл бұрын

Sandra Jackson thanku sir

may I ask something, what is exactly the meaning of "strength" of a product?? great video btw

@PharmaPill

3 жыл бұрын

Strength is the amount of drug in a given dosage form.

@shadidi

3 жыл бұрын

@@PharmaPill thank you so much

Thax you so much sir for this video

@saritasawji5635

3 жыл бұрын

Sir please next topic 21CFR

Background music???

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.

@EducationEuphoria

6 ай бұрын

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.

When to apply 1/2 and when to apply 1/3 reduction...?

@PharmaPill

Жыл бұрын

It’s upto you whichever you want to follow

Very good explanation brooo

@PharmaPill

3 жыл бұрын

Thank you so much 🙂

Superb video

@PharmaPill

5 жыл бұрын

rashmin patel 🙏🏼 happy learning

@rashmin250785

5 жыл бұрын

Plz made video on other guidelines ..this is best easiest way u teach bracketing and matrixing

@PharmaPill

5 жыл бұрын

rashmin patel noted 😊

Good information

@PharmaPill

4 жыл бұрын

Thanks

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

@EducationEuphoria

6 ай бұрын

"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.

Brother we don't found oos part 2 video in you tube plz upload it We are waiting

@PharmaPill

5 жыл бұрын

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.

@PharmaPill

Жыл бұрын

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.

@PharmaPill

4 жыл бұрын

Nayab Singh Constructive criticism is always welcome.

Reduce background voice

your background music and english...pain

@PharmaPill

3 жыл бұрын

Even I do feel exactly 😊