I work in pharmaceutical research for an MNC, and I have to say, that you've done a fantastic job of explaining and summarizing the information.
@tamngoc9394 Жыл бұрын
ICH Q3B (R2) summarized in detailed and intelligible in less than 30 minutes. Your presentation has saved me from lots of troubles. Many thanks!
@ChaandTaaree Жыл бұрын
Thank you sir, I struggled for many years to understand each concept until watched this video 🙂
@keerthikishore69828 күн бұрын
I'm very very clarified with impurity guidelines Really good explanation
@sanjaykale71573 жыл бұрын
Thank you sir for your presentation. Packed a lot of information into a short time. with a very simple and understandable language.
@damthithanhhuong19942 жыл бұрын
Thank you so much for the detailed presentation. That helped me understand the ICH guideline for impurity limit establishment as well the meaning of each definition in glossary. I read the guideline several times but cannot understand until I saw your video. I can apply this understanding to some questions in the DL response of Drug Submission that I have to deal with recently . Your video really helps.
@pseudotalli3 жыл бұрын
each and every concept is explained very nicely. You truly are the best teacher.
@sunilshedage95033 жыл бұрын
Very informative and knowledge improvement presentation. make videos like this. Thank you lots Sir
@hanumantgare18912 жыл бұрын
Each and every point explain clearly with examples. Thanku sir
@tejaswinunnam86462 жыл бұрын
This is the best explanation for this topic.Thank you!
@prasadrane43772 жыл бұрын
U r really good teacher👍
@user-nd9xh3pd7p Жыл бұрын
Thank you for a great lecture where I found answers to many of my questions. How should the limit of Total impurities be calculated in the case of a combined drug (fixed-dose combination)? It is logical that each API should have its own limit specified in the Specification, but this is not explicitly stated in the EMA guidelines.
@prashantpandit78062 жыл бұрын
Superb Explanations Cleared the Doubt..👍🏻
@neelammahadik814612 күн бұрын
Thank u sir.. Explained in very simple language with examples tht is very helpful.. Looking forward for more informative videos. If possible plz present on PDE calculation.
@priyankapathak48823 жыл бұрын
Amazing mond map sir! Understood each concept distintly!! Ur a great teacher!
@duppatigattuaru12232 жыл бұрын
Really its amazing sir, ur giving very knowledge to us thank you sir, and if possible show the guideline page also directly this is my request sir.
@saravananram39602 жыл бұрын
Excellent video sir
@chinna26803 ай бұрын
Tq so much sir now I got the difference between these limits
@vinittiwari67773 ай бұрын
Explained very well sir.
@anantdhopat99282 жыл бұрын
Excellent explanation to understand, thanks sir 👍
@HarikrishnaTirumala9 Жыл бұрын
Your videos helped me alot to get job sir . Thank you so much Guruji .🙏🙏🙏
@omjoshi51113 жыл бұрын
superb presentation
@RashidAnsari-dk9mk Жыл бұрын
Aapne bahut achcha explain kiya...or ICH me bhi kuch jyada difficult nhi likha h...But I am very sad to see this all information available just a click away and still people who are working in pharma since 10 yrs still they are unable to answer some questions at this topic. Or fir kehtey h ki pharma me salary achchi nhi h future achcha nhi h...
@user-rr3tz2il3f8 ай бұрын
Useful Information sir
@pharmagrowthhub30838 ай бұрын
glad that you found info useful!
@bhattkishan66075 ай бұрын
Very nice explanation and important information 👌👌👍👍👍
@rajbala3114 Жыл бұрын
Hi sir , your presentations are good and helpful ,can I get your presentations in PDF form ?
@harikrishnanayyappan91793 ай бұрын
Great sir
@mevibhuti2 ай бұрын
Very well explained sir 😊
@alimir81128 ай бұрын
Great Work Mr. Bhaskar Napte
@vinayakwadgaonkar51833 жыл бұрын
very informative presentation sir
@vijayagrawal26282 жыл бұрын
Great presentation sir..request to make video on solubility studies as per USP chapter.It will be very useful for all. Thank you
@mangeshgawade10425 ай бұрын
Very nice sir
@ichaffairs46193 жыл бұрын
What a teacher you are sir....... fabulous
@mudassirshaikh62139 ай бұрын
Tooo easy to understand and time saving thank you sir...
@shantanughodke1224 Жыл бұрын
Good content
@mitaligaikwad11523 жыл бұрын
Very nice presentation...could you please explain how to calculate regulatory qualification threshold for drug substances
@PharmaceuticalConcept3 жыл бұрын
Amazing video on impurities #pharmaceuticalconcept
@bhargavrana5064 Жыл бұрын
Thank you very much sir🙇🙇 it's easier understand than ICH guidline
@user-it5sj9es2u5 ай бұрын
Hello Sir, Many thanks for explaining entire concept in very simple and understandable way. Could you please let us know that. does unknow also called as unspecified impurity or unspecified impurity is different then unknown impurity? Your prompt response is highly appriciated!
@sureshpottella22303 жыл бұрын
Excellent session.
@baraiyavimal1023 жыл бұрын
Really nice explained sir.👍
@kapilkulkarni25942 жыл бұрын
very informative and easily understandable information , thanks sir
@venkataratnams5406 Жыл бұрын
Nice class
@dr.balakrishnaaegurla55602 жыл бұрын
super sir
@yogeshmandole59532 жыл бұрын
sir please keep it up, it's really so usefull at times of interview
@damthithanhhuong1994 Жыл бұрын
Hello teacher, may I ask if this guideline is to define limit for release specification or shelf life specification?
@PKvaghela01113 жыл бұрын
Amazing Sir
@krishasworld17373 жыл бұрын
Very nice information explained well
@computerlearners46362 жыл бұрын
really great way of explanation sir
@swapnilchitte60463 ай бұрын
Thank you so much sir,it is really helpful...
@chinatobdvisit95782 жыл бұрын
Thank you very much for share about impurities
@pankajkhadakban1872 жыл бұрын
Very Nicely Explained..Sir..
@bhushanborse917 Жыл бұрын
Good information sir,
@ramakrishnaguttula7941 Жыл бұрын
Excellent video sir 👏
@Ram-nn6xr2 жыл бұрын
Just small question sir, the specified unknown was added in the list, but how about the unspecified limit of 0.2%? Does the specified unknown even cover this too?
@amritarajput2597 Жыл бұрын
So nicely explained sir
@muralikrishna28522 жыл бұрын
Excellent information
@dilipwagdarikar7642 жыл бұрын
Nicely explained Sir
@user-wx3or4tr2g Жыл бұрын
Very nice explained
@Tushar338653 жыл бұрын
Thank you sir,
@sharmilassharmilas50712 жыл бұрын
Very nice explanation sir
@tusharadm3 жыл бұрын
Good presentation
@Dileeppharma2 жыл бұрын
awesome task sir
@harshinikotichinthala84803 жыл бұрын
Sir as per finished product specifications limit of specified impurities and unspecified impurities
@ichaffairs46192 жыл бұрын
Dear sir, Kindly also prepare the video about DS impurity (degradent impurity)which is above the qualifications limit and suggest the calculation of how to prepare justification in sec. 3.2.S.3.2 on base repeat dose tox. Study NOAEL. Thank you for above video, it's helpfull
@manojkadam59842 жыл бұрын
Very nicely explained 👍
@AjayKumar-eo6em2 жыл бұрын
Useful information 🙏
@dheerajsharma93042 жыл бұрын
Very help full
@madhuchandral57782 жыл бұрын
Good Explanation Thank you.
@sanjays13443 жыл бұрын
Excellent, thank you sir
@narresreenivas6213 Жыл бұрын
Thanks a lot sir
@pseudotalli3 жыл бұрын
in case of drug substance having daily dose of more than 2gm per day, the identification and quantification threshold is 0.05%, does that mean that both known and unknown impurties in my drug substance will have the same limit, if the product is official in any of the monograph
@thirupugazhmg674Ай бұрын
Thanks sir..❤
@DeepakKumar-te2xl8 күн бұрын
How to know maximum daily dose for the product
@rahulkulkarni30372 жыл бұрын
Well explained 👏
@stockspower34102 жыл бұрын
Very nice 👌👌
@saradaverans Жыл бұрын
Thanks sir
@mohdjouma9437 Жыл бұрын
What is the software you use to make these nice collapsible and expandable boxes
@bandikattuvenkatasiva25422 жыл бұрын
Super sir, thank you so much sir
@vivekrajkotia37303 жыл бұрын
Nice presentation sir. 👍Keep posting such type of videos. Btw can i know the presentation software you were using for preparation?
@pharmagrowthhub30833 жыл бұрын
Hi Vivek, thank u, its a mind map.
@vivekrajkotia37303 жыл бұрын
@@pharmagrowthhub3083 thank you sir
@achyutjagdhane96833 жыл бұрын
THANK YOU , EXCELLENT
@sankarreddy6996 Жыл бұрын
Sir If possible make a video on ICH Q6A
@shibithaanadar10894 ай бұрын
Sir from were we r calculating X? Value
@sureshpatel8108 Жыл бұрын
What is the meaning of impurity above qualifications threshold
@maheshgupta5643 жыл бұрын
Good concepr
@sarikanalam124924 күн бұрын
For qualifying higher limit how many batches of RLD needs to be analysed ?
@krish_krish3543 жыл бұрын
How to know the daily dosage for api drug substance. You have given for products
@srinivasaraovenkatasriniva4387 Жыл бұрын
Hi sir I want to know on which guidelines basis we fix a run time for RS AND ASSAY
@abhishekjoshi96502 жыл бұрын
Thank you
@deepaksingla43272 жыл бұрын
Sir how I can find the MDD value for any drug because in PIL I don't get the MDD VALUE Of most of the drugs. if there is any other approach then plz tell me.
@damthithanhhuong19942 жыл бұрын
You can find In EMC-UK/MHRA, FDA, EMA, TGA web. They have many SmPC and provide dosage information.
@003anwar2 жыл бұрын
If any impurity limit is 0.5%, then is it possible to calculate the LOQ value theoretically?