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Learn With Simon
Добавлен 12 янв 2014
Nitrosamines I EP 02 I Regulatory Requirements, Analytical Methods, AI Limits & Mitigation Strategy
Dear Viewers, This is the Second episode of the Nitrosamines Impurity Series. In this video, I have described the regulatory requirements for Nitrosamines, AI Limits, Calculations of AI Limits, Analytical Methods, and Mitigation strategies.
Please watch and video share your feedback in the comments section.
Link for FDA nitrosamine guideline:
www.fda.gov/media/141720/download
Link for EMA Nitrosamine guideline:
www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders/applicants-chmp-opinion-article-53-regulation-ec-no-726/2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf
List of Analytical Methods:
Health Canada:
www...
Please watch and video share your feedback in the comments section.
Link for FDA nitrosamine guideline:
www.fda.gov/media/141720/download
Link for EMA Nitrosamine guideline:
www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders/applicants-chmp-opinion-article-53-regulation-ec-no-726/2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf
List of Analytical Methods:
Health Canada:
www...
Просмотров: 129
Видео
Basics of Nitrosamines Impurities I EP 01 I Origin, Definition, Root Cause & Control
Просмотров 117Год назад
Dear Viewers, This is the first episode of the Nitrosamines impurity Series. In this video, I have described the basics of nitrosamines including it's origin, chemical reaction, the root cause of formation and the control strategy. Please watch and video share your feedback in the comments section. Link for FDA nitrosamine guideline: www.fda.gov/media/141720/download Link for EMA Nitrosamine gu...
Reference Listed Drug (RLD) & Reference Standard (RS) I Referencing approved drug product in ANDA
Просмотров 893Год назад
Dear Viewers, In this video, I discussed the difference between a reference listed drug (RLD) and a reference standard (RS) in the context of abbreviated new drug applications (ANDAs). I also explained what to do as an ANDA applicant when your RLD is discontinued from market. Key takeaways: 1. The RLD is the specific listed drug that an ANDA applicant relies on in seeking approval for its ANDA....
How to Search Orange Book Database I FDA I Approved Drug Products with Therapeutic Equivalence
Просмотров 522Год назад
Dear Viewers, In this video I have demonstrated how to search an orange book database. The Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations, is a publication of the U.S. Food and Drug Administration (FDA). It lists all prescription drug products approved by the FDA, along with information about their patent and exclusivity protections. This video is ess...
Overview of Orange Book (In Hindi) I Approved Drug products I FDA
Просмотров 1,2 тыс.Год назад
The Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations, is a publication of the U.S. Food and Drug Administration (FDA). It lists all prescription drug products approved by the FDA, along with information about their patent and exclusivity protections. This video provides a comprehensive overview of the Orange Book, including: What is the Orange Book and ...
ICH Q1A in Detail- Stability testing on New Drug Substance & Product
Просмотров 3 тыс.Год назад
This is a detailed discussion of ICH Q1A guideline in simple language. I have also covered most of the interview questions from this guideline. Please watch the full video and please let me know your feedback in the comment section. Link to Basics of ICH Part 1: ruclips.net/video/Jp2EYVhr5wE/видео.html&ab_channel=ChatWithSimon Link to Basics of ICH Part 2: ruclips.net/video/47iHCwnL1LM/видео.ht...
Important Terminologies to Understand ICH Quality Guidelines
Просмотров 269Год назад
In this video, I have explained the most Important terminologies, which everyone should know before going through the ICH Quality guidelines. From the next video onwards, we will dive into the nitty-gritty of the Regulatory requirements regarding the Quality Guidelines of ICH. Please subscribe to this Channel, watch the full Video & let me know your comments. Link to ICH Basics of ICH Part 1 ru...
Basics of ICH PART 2 (The only video you need to watch about ICH)
Просмотров 166Год назад
Have you ever thought about how ICH guidelines are generally developed? In this video, I have explained it in a very simple language. Please see the full video and let me know your comments. The contents of the Part 2 are given below, 5. ICH Expert Working Group 6. Steps of ICH Guidelines Development The link for the ICH Part 1 Video is given below, ruclips.net/video/Jp2EYVhr5wE/видео.html&ab_c...
Basics of ICH PART 1 (The only video you need to watch about ICH)
Просмотров 369Год назад
Have you ever thought how ICH got established and how it's guidelines are generally developed? In this video, I have explained it in a very simple language. Please see the full video and let me know your comments. The contents of the Part 1 are given below, 1. Background 2. Origin & Objectives 3. ICH Members & Status of India 4. ICH Guidelines The link for my Introduction Video is given below, ...
thank you sharing knowledge
Very well explained appreciated
Excellent Explanation Simon👏
🙌🙌🙌
Great video ....Please keep posting such amazing content.
Dear please explain reference std and reference listed drugs in hindi
Nice explaination sir, keep it up....
Bro why stop making videos
Thank you for your interest. This channel will be active again starting next month.
Thank you 🙏
very informative and well explained
Great experience, Eager for other videos
Thank you for your interest. New videos will come again starting next month.
Can you cover other imp quality guidelines like specification and analytical validation
Yes sir please
Thank you for your interest. Sure, I will cover these topics. This channel will be active again starting next month.
Thank you sir. Very nicely explain
For corrected you intermediate testing period cover 12 M
Hello 👋👋 Is there any video for the "Medical Device" stability study? Like the testing period for real time shelf life stability study or accelerated study. It would be very helpful for me 🤠🤠
👏
Learnt a lot from it. Thank you for the video.
"Promo sm"
Hi Simon! Thank you for covering the requested topic!
My pleasure!
Nicely presented!
Good one 🎉
Nice video! Keep going!
Nice bro informative for Quality assurance
What are the other ways to market drug in US other than NDA and ANDA?
Thanks for asking this. There are couple of ways to market drug in US other than NDA and ANDA. For example, 1. OTC monograph Process: To bring non-prescription drugs into the market which are not approved under the section 505 of the FD&C Act. This has to follow Section 505G of the FD&C Act. 2. Biologics Licence Application (BLA): For Biologics drug products. These informations are available in Purple Book. 3. New Animal Drug Application (NADA)/ Abbreviated New Animal Drug Application (ANADA): To bring Animal drugs in to the US martket. These informations are avaliable in Green book.
Thank you for the informative video!
Very well explained!
Very informative ..Keep posting
Nicely explained!
Amazing! Very well explained!! Keep posting more 🙌🏻❤
Thank you for for the gross description of commonly used terminology. Easy to understand.
Thanks for the video. Very informative. I didn't know about these 5 steps.
ICH says stability should be done on secondary packaging... Brazil says stability should be done in primary packaging... Brazil implemented ICH Q1 in 2019. Isn't that contradictory?
That's a great question @chandansaini98. Yes, it is contradictory. ANVISA requirement for stability in primary packaging is more stringent than secondary packaging. Although, after adoptation of ICH Q1 in 2019, it was supposed to be harmonized with the other regions but it is not. May be in upcoming times, ANVISA will make it harmonize.
Keep up the good work!
Wooww❤
Very informative. Keep it up 😊
Thanks a lot 😊
Keep it up 🎉all d best 👍
Very good initiative Simon....keep it up...keep growing....All the best
Keep up the good work 👍
Great explanation sir. We are expecting more educational videos from you sir. 👏👏👏👏👏👏👏👏👏👏👏👏👏👏👏👏👏👏👏👏
Sure 👍
Great start, very informative and planned content. Proud of you 👏
Thanks a ton ☺️
Great explanation with depth and simplicity, really needed this. Thankyou so much
Glad it was helpful 😀.