Drug Safety
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New Drug Application (NDA): Key Components & FDA Approval
Dive deep into the world of drug development! This video explains the New Drug Application (NDA), the crucial document that pharmaceutical companies submit to the FDA for drug approval. Learn about the key components of an NDA, including preclinical data, clinical trial results, manufacturing details, and labeling information. Understand the rigorous review process the FDA undergoes to ensure the safety and effectiveness of new medications.
#NDA #NewDrugApplication
#FDA #DrugApproval
#PharmaceuticalIndustry
#DrugDevelopment
#ClinicalTrials
#DrugSafety
#DrugEfficacy
#Healthcare
#Medicine
#Science
มุมมอง: 291

วีดีโอ

The Story of Paracetamol
มุมมอง 1443 หลายเดือนก่อน
Did you know that one of the world’s most popular pain relievers was discovered over 100 years ago-by accident? 🎉 Follow the fascinating journey of paracetamol, from 19th-century scientists experimenting with willow bark remedies to the modern-day medicine cabinet essential that helps millions every day. Discover how a forgotten compound became a life-changing breakthrough! 💊✨ #Pharmacovigilanc...
Medical Literature Monitoring
มุมมอง 9067 หลายเดือนก่อน
Why Literature Reviews Matter in Pharmacovigilance In this video, explore the critical role of literature reviews in pharmacovigilance, the science of monitoring drug safety. Discover how these reviews unearth safety signals that might be missed by spontaneous reporting alone. Learn why literature reviews are essential for ensuring medication safety and how they contribute to regulatory require...
Trial designes in clinical trials
มุมมอง 1568 หลายเดือนก่อน
Confused by all the clinical trial acronyms? This video breaks down the different types of clinical trials (Phase I, II, III, IV) in an easy-to-understand way! #clinicaltrials #clinicalresearch #health #medicine #science #phases #research #medicaldiscovery Ready to Make a Difference? This video can help you decide if participating in a clinical trial is right for you. Leave a comment below with...
Investigational New Drug Application: Key to Starting Clinical Trials | Regulatory Affairs
มุมมอง 4.7K10 หลายเดือนก่อน
Embark on the journey of human clinical trials with Investigational New Drug Application as your guiding key. In this video, we delve into the crucial steps involved in initiating clinical trials for new drugs in humans. Learn how Investigational New Drug Application serves as the gateway to transitioning from research to real-world testing. Exploring Elon Musk's Neuralink Brain Chips: Link : t...
Oxytocin the "LOVE ❣️ HORMONE"
มุมมอง 188ปีที่แล้ว
Oxytocin the "LOVE ❣️ HORMONE"
EudraVigilance & Pharmmacovigilance
มุมมอง 1.4Kปีที่แล้ว
EudraVigilance & Pharmmacovigilance
Neuralink Brain Chip
มุมมอง 368ปีที่แล้ว
Neuralink Brain Chip
What is Placebo 💊💉
มุมมอง 621ปีที่แล้ว
What is Placebo 💊💉
Pharmacovigilance Resume for freshers
มุมมอง 2.7Kปีที่แล้ว
Pharmacovigilance Resume for freshers
Observational Study explained with example
มุมมอง 7K2 ปีที่แล้ว
Observational Study explained with example
Thalidomide: The Drug That Caused Birth Defects
มุมมอง 13K2 ปีที่แล้ว
Thalidomide: The Drug That Caused Birth Defects
The Different Types of Clinical Research You Should Know About!
มุมมอง 1.7K2 ปีที่แล้ว
The Different Types of Clinical Research You Should Know About!
Sulphonilamide Disaster: The Rise and Fall of Sulfanilamide
มุมมอง 6K2 ปีที่แล้ว
Sulphonilamide Disaster: The Rise and Fall of Sulfanilamide
Why Adverse Drug Reactions experienced ?
มุมมอง 1.2K3 ปีที่แล้ว
Why Adverse Drug Reactions experienced ?
Government Jobs for Pharmacist
มุมมอง 3K3 ปีที่แล้ว
Government Jobs for Pharmacist
Job after pharmacy
มุมมอง 2K3 ปีที่แล้ว
Job after pharmacy
Baby and Fetus Case Processing in Pharmacovigilance/Pregnancy case processing/ Special case scenario
มุมมอง 2.6K3 ปีที่แล้ว
Baby and Fetus Case Processing in Pharmacovigilance/Pregnancy case processing/ Special case scenario
Mother case processing in pharmacovigilance/Pregnancy case processing/Pharmacovigilance interview
มุมมอง 2.5K3 ปีที่แล้ว
Mother case processing in pharmacovigilance/Pregnancy case processing/Pharmacovigilance interview
Pregnancy Case processing in Pharmacovigilance/Special Situation Report/Pharmacovigilance interview
มุมมอง 3.1K3 ปีที่แล้ว
Pregnancy Case processing in Pharmacovigilance/Special Situation Report/Pharmacovigilance interview
Adverse Drug Reaction form filling: Tutorial on PvPI Application
มุมมอง 2.2K3 ปีที่แล้ว
Adverse Drug Reaction form filling: Tutorial on PvPI Application
ADR Reporting/ Adverse Drug Reaction Reporting in India/ SAE Reporting/Health reporting/Pharmacy job
มุมมอง 6K3 ปีที่แล้ว
ADR Reporting/ Adverse Drug Reaction Reporting in India/ SAE Reporting/Health reporting/Pharmacy job
How to Assess the Seriousness of a Case (Serious/Non-serious): Pharmacovigilance Case Processing
มุมมอง 7K3 ปีที่แล้ว
How to Assess the Seriousness of a Case (Serious/Non-serious): Pharmacovigilance Case Processing
Understand Health & Regulatory Authority case in 3 minutes: Pharmacovigilance Case Processing
มุมมอง 4.6K3 ปีที่แล้ว
Understand Health & Regulatory Authority case in 3 minutes: Pharmacovigilance Case Processing
AESI: What you need to know?
มุมมอง 6K3 ปีที่แล้ว
AESI: What you need to know?
Clinical Trials in Pharmacovigilance (An overview)/ Interventional study/ Drug Development process
มุมมอง 12K3 ปีที่แล้ว
Clinical Trials in Pharmacovigilance (An overview)/ Interventional study/ Drug Development process
MedDRA Coding in Pharmacovigilance | Complete Guide to MedDRA Dictionary
มุมมอง 36K3 ปีที่แล้ว
MedDRA Coding in Pharmacovigilance | Complete Guide to MedDRA Dictionary
Nullification and Logical Deletion of ICSR in Pharmacovigilance/Pharmacy Job interview/ PV interview
มุมมอง 10K4 ปีที่แล้ว
Nullification and Logical Deletion of ICSR in Pharmacovigilance/Pharmacy Job interview/ PV interview
Private Jobs After B.Pharma and M.Pharma/Best highest paying jobs after B.Pharm/Job after Pharmacy
มุมมอง 78K4 ปีที่แล้ว
Private Jobs After B.Pharma and M.Pharma/Best highest paying jobs after B.Pharm/Job after Pharmacy
🔍 Lack of Drug Effect in Pharmacovigilance (LOE) and Special Situation Report
มุมมอง 8K4 ปีที่แล้ว
🔍 Lack of Drug Effect in Pharmacovigilance (LOE) and Special Situation Report

ความคิดเห็น

  • @bhagyavathi5194
    @bhagyavathi5194 วันที่ผ่านมา

    Pls do topic on aggregate reporting complete vedio ❤

    • @DrugSafety
      @DrugSafety วันที่ผ่านมา

      Next one will be on this topic

  • @jeetcollection
    @jeetcollection 19 วันที่ผ่านมา

    Clairty is missing. It was confusing.

    • @DrugSafety
      @DrugSafety 17 วันที่ผ่านมา

      Please elaborate on the confusing part so we can clarify that in next video..

  • @NikhilaKandanooru
    @NikhilaKandanooru หลายเดือนก่อน

    seriously ur really great man it really helped me 😍🥰

    • @DrugSafety
      @DrugSafety หลายเดือนก่อน

      Glad to hear that...thanks for the comment..this means a lot

  • @AbhishekRoy-zr4ir
    @AbhishekRoy-zr4ir หลายเดือนก่อน

    Very informative 👏 👌

    • @DrugSafety
      @DrugSafety หลายเดือนก่อน

      Thank you 👍

  • @FarjanaSutar
    @FarjanaSutar หลายเดือนก่อน

    Current medical discussion should involve this topic.It is very important topic in view of patient safety.

  • @Nikky440
    @Nikky440 3 หลายเดือนก่อน

    Make video on CMDH and EPAR

  • @AnjaliSehgal-m9i
    @AnjaliSehgal-m9i 4 หลายเดือนก่อน

    🤗

  • @raghun287
    @raghun287 4 หลายเดือนก่อน

    Great information

  • @pranavilagisetty8143
    @pranavilagisetty8143 4 หลายเดือนก่อน

    How to trigger AESI form in rave others watching this comments can also help

  • @kasisuresh
    @kasisuresh 5 หลายเดือนก่อน

    Very crisp and well explained

    • @DrugSafety
      @DrugSafety 5 หลายเดือนก่อน

      Thank you 👍

  • @ayubqureshi3685
    @ayubqureshi3685 5 หลายเดือนก่อน

    This content deserve million of likes and view's

    • @DrugSafety
      @DrugSafety 5 หลายเดือนก่อน

      Thanks a lot for comment.. This means a lot for us..please share the content to your circle for better reach for our channel..

  • @vedaprakash-h1h
    @vedaprakash-h1h 5 หลายเดือนก่อน

    7 days for only clinical trail cases

    • @DrugSafety
      @DrugSafety 5 หลายเดือนก่อน

      Nice suggestion 🙂 will try to create...suggest some related topics if you have in mind to start with

    • @vedaprakash-h1h
      @vedaprakash-h1h 5 หลายเดือนก่อน

      @@DrugSafety do an video on Medical literature monitoring

  • @jitendranagar2431
    @jitendranagar2431 6 หลายเดือนก่อน

    Dear Team, this is not investigated by Dr Kalsey, she was involved in the Thalidomide tragedy don't mislead the facts.

    • @DrugSafety
      @DrugSafety 6 หลายเดือนก่อน

      Please read the wikipedia page of Dr Kalsey. She did assisted in this investigation as well. For thalidomide you can watch my video on thalidomide then it will be clear for you..so this is not a misleading information..thanks for the comment..

  • @paritapatel7008
    @paritapatel7008 6 หลายเดือนก่อน

    Do we have to delete case after nullification of reports?

  • @janetbusener6326
    @janetbusener6326 7 หลายเดือนก่อน

    My Mom took it with me because the doctor told her she would not miscarry. I am so happy to have arms and legs. As short as they are, I can still drive a car and live alone.

    • @DrugSafety
      @DrugSafety 7 หลายเดือนก่อน

      That's good to hear Janet. Happy for you..😊

  • @BUY_YOUTUB_VIEWS_994
    @BUY_YOUTUB_VIEWS_994 7 หลายเดือนก่อน

    Your videos always brighten my day.

  • @markandeyaguptachekka-hg6pb
    @markandeyaguptachekka-hg6pb 7 หลายเดือนก่อน

    Please clarify differences between off label drug use and medication error!

    • @DrugSafety
      @DrugSafety 7 หลายเดือนก่อน

      Already created please check the channel content, below is the 🖇️ th-cam.com/video/LyJj__G9pGs/w-d-xo.html

  • @markandeyaguptachekka-hg6pb
    @markandeyaguptachekka-hg6pb 7 หลายเดือนก่อน

    Please clarify difference between off label use and maladminisratin of drugs!

    • @DrugSafety
      @DrugSafety 5 หลายเดือนก่อน

      OFF-LABEL drug use refers to prescribing a medication for an unapproved indication, dosage, or patient group. For instance, using the antidepressant amitriptyline to treat neuropathic pain is a common off-label use. In contrast, maladministration involves the incorrect administration of a drug, which can lead to harm. An example would be giving a medication via the wrong route (e.g., injecting a drug meant for oral use), potentially causing adverse effects or treatment failure. OFF-LABEL USE is legal and often clinically justified, while maladministration is a misuse that can have serious consequences. Hope I answered the ❓

  • @arnabartworld6728
    @arnabartworld6728 7 หลายเดือนก่อน

    Sir bca or bpharm which is best i want more money within 4 to 5 years

  • @arnabartworld6728
    @arnabartworld6728 7 หลายเดือนก่อน

    Sir which online sas certification is best pls suggest is certificate which is provided free by sas itself in online valid to get job?

    • @DrugSafety
      @DrugSafety 7 หลายเดือนก่อน

      Will create a seperate video on sas certification. And I guess most of the ur question I have answered on Instagram.. if u have any further questions I can message me on instagram.

  • @Asmamahmoud-b2c
    @Asmamahmoud-b2c 7 หลายเดือนก่อน

    u made he topic easy . Plz we need a topic on MedDRA coding for ADRs

    • @DrugSafety
      @DrugSafety 7 หลายเดือนก่อน

      Sure will create soon

  • @surajsahay4945
    @surajsahay4945 8 หลายเดือนก่อน

    Awesome video ❤

    • @DrugSafety
      @DrugSafety 8 หลายเดือนก่อน

      Thank you 😊

  • @najishshaikh9406
    @najishshaikh9406 8 หลายเดือนก่อน

    I really admire your skills. You're so talented!.... Nice so informative 👍

    • @DrugSafety
      @DrugSafety 8 หลายเดือนก่อน

      Thanks a lot 👍

  • @najishshaikh9406
    @najishshaikh9406 8 หลายเดือนก่อน

    Very helpful thank you ☺️

  • @a.k.6938
    @a.k.6938 8 หลายเดือนก่อน

  • @asminoorudhin9361
    @asminoorudhin9361 9 หลายเดือนก่อน

    Perfect

    • @DrugSafety
      @DrugSafety 9 หลายเดือนก่อน

      Thanks for the comment 😊

  • @sailaharicherukuthota4831
    @sailaharicherukuthota4831 9 หลายเดือนก่อน

    Hi drug safety team I got job as senior Pv associate after listening ur videos I answered so many questions.. Thank you so much

    • @DrugSafety
      @DrugSafety 9 หลายเดือนก่อน

      Congratulations 🥳🎉 Thanx for the comment, I am very much happy to hear this.. It motivate us to create such content..All the best 😄

    • @sushmarey1337
      @sushmarey1337 4 หลายเดือนก่อน

      Sir which company r u working

  • @stevelucier8346
    @stevelucier8346 9 หลายเดือนก่อน

    Amazes me all these decades to still see totally incorreect reports of the history of thalidomide. Yet I Must Fight one correcting the story. Perhaps the following will lead to futher research so discovery can be shared properly. There are too many points in this vdieo incorrect so suffice it to provide the following: ( "US Thalidomide Survivors" site and youtubes ) ( "PHARMA The Movie" site and youtubes ) ( C. Jean Gorver youtubes ) " th-cam.com/video/rVroy5BeOPM/w-d-xo.html " <-- US Thalidomide Community 60th Anniversary greeting. " th-cam.com/video/3bLH1ENANLo/w-d-xo.html " <-- Thalidomide in the USA: the Forgotten Survivors. " th-cam.com/video/dO_LrVZ9wS0/w-d-xo.html " <-- Thalidomide in the USA: Seeking a Life of Dignity and Independence. NOTE: In some presentations of "PHARMA The Movie" still in the works April 2024 you will see indicators that thalidomide was used in WWII. I have found as well as others pregnant mothers were given thalidomide in WWII. Pregnant rats and mice were given thalidomide pre 1955 anf it was known to create birth defects in them also. Start your journey of revealing the real history as much as can be found. Some of the files to this day are locked away inside one German court sealed by court order in the 1960 to never be revealed. The evidences can be found. Much a matter of court records in the USA now and the US Thalidomide Survivors should soon begin to have those court records so they can even better know and reveal the truths available. Please Share our story shown in the provided videos. Many need Stair Lift Platforms ASAP and they are not cheap.

    • @DrugSafety
      @DrugSafety 8 หลายเดือนก่อน

      Thanks for the detailed comment. I will try to cover a points raised by you in my follow up video on the same topic.

  • @i_mermaid
    @i_mermaid 10 หลายเดือนก่อน

    Template not opening

    • @DrugSafety
      @DrugSafety 10 หลายเดือนก่อน

      Please check now..link is updated in the description...hopefully you will be able to download now.. 🙂

  • @DCFunBud
    @DCFunBud 10 หลายเดือนก่อน

    God, no whistling!

    • @DrugSafety
      @DrugSafety 10 หลายเดือนก่อน

      Correct.. bad choice of music

  • @gowthamivoonna1790
    @gowthamivoonna1790 10 หลายเดือนก่อน

    Pls explain the difference between E2b R2 and E2b R3

    • @DrugSafety
      @DrugSafety 10 หลายเดือนก่อน

      Sure

  • @vasimkhatik8062
    @vasimkhatik8062 10 หลายเดือนก่อน

    Good information about IND application 👍

  • @RohitKu91
    @RohitKu91 10 หลายเดือนก่อน

    🔍 Exploring pharmacovigilance? Dive deeper into this crucial field with our channel! 📚 From insightful discussions to practical tips, we've got you covered. Join our community today for valuable content on drug safety and more. Don't miss out, subscribe now! ➡ [Link: th-cam.com/channels/PeXZIPYxjF3X9LJCbdvhvg.html] #Pharmacovigilance #DrugSafety #Subscribe"

  • @aswinraj1179
    @aswinraj1179 11 หลายเดือนก่อน

    Hi

    • @DrugSafety
      @DrugSafety 11 หลายเดือนก่อน

      Hello

  • @secret._.vlogger
    @secret._.vlogger ปีที่แล้ว

    Your all vdo was aswm expect this because of ur voice. Keep that computerized voice

    • @DrugSafety
      @DrugSafety 10 หลายเดือนก่อน

      I will try my best next time 😄

  • @LaurieMarieValdezRNCCRN
    @LaurieMarieValdezRNCCRN ปีที่แล้ว

    🤬

  • @LaurieMarieValdezRNCCRN
    @LaurieMarieValdezRNCCRN ปีที่แล้ว

    POISION

  • @anbumanir3319
    @anbumanir3319 ปีที่แล้ว

    Off lable is a error or good one based on situation

    • @DrugSafety
      @DrugSafety ปีที่แล้ว

      It's best for that perticular patient in that perticular time as per the physician/doctor. Drug is given off labelly as per doctor's suggestion based on certain criteria such as patients medical history,for early recovery etc. Hope this clears your doubt. Let me know if anything else is needed. Thanx for the comment 🙂

  • @Gman-j3e
    @Gman-j3e ปีที่แล้ว

    Please,please come to the knowledge of God through Jesus Christ, this was prophecied in the book of revelation in the Bible, it's the mark of the beast! whoever takes it is damned for all eternity

  • @kshitijagonge7890
    @kshitijagonge7890 ปีที่แล้ว

    How nullification case we can overlook or view in psur or dsur?

  • @najishshaikh9406
    @najishshaikh9406 ปีที่แล้ว

    Nice video... just one thing music is quite loud... overall good content n informative video 👍👍👍

    • @DrugSafety
      @DrugSafety ปีที่แล้ว

      Thanks for the comment and suggestions 🙂 will take care of music next time

  • @anchiebauyon1002
    @anchiebauyon1002 ปีที่แล้ว

    thank you so much! this is really helpful! ^_^

    • @DrugSafety
      @DrugSafety ปีที่แล้ว

      Thanks for the comment 🙂

  • @sarthakghodake31
    @sarthakghodake31 ปีที่แล้ว

    Sir according to salary perspective, should i get into clinical SAS field or go for M. pharm?

    • @DrugSafety
      @DrugSafety ปีที่แล้ว

      I would suggest to go with M.pharm and along with M. Pharm do 1 years clinical SAS online certification course.. all the best

    • @sarthakghodake31
      @sarthakghodake31 ปีที่แล้ว

      @@DrugSafety sir the M.pharm will be of no use only the certification is important and even all the jobs are given for bachelor aslo, so is M.Pharm that necessary

    • @skullkandyioper
      @skullkandyioper ปีที่แล้ว

      ​@@sarthakghodake31konsa course hai ?

  • @shanvisri6813
    @shanvisri6813 ปีที่แล้ว

    You missed about premature baby case i.e., delivered before 38 weeks

    • @DrugSafety
      @DrugSafety ปีที่แล้ว

      This can be included in baby case itself with an event, premature baby (whatever the prematurity reported).. please let me know if you have any other thoughts 💬

  • @odyakabueze5337
    @odyakabueze5337 ปีที่แล้ว

    Your videos are clear are concise. Thank you so much.

    • @DrugSafety
      @DrugSafety ปีที่แล้ว

      Thanx for the comment 😀 This means a lot

  • @abinashalagar5088
    @abinashalagar5088 ปีที่แล้ว

    which is the high paid job in pharma sector... I'm a b.pharm graduate sir...plz help for my career

    • @DrugSafety
      @DrugSafety ปีที่แล้ว

      Currently CDM is in demand field which provide good salary. Suggest to get job in CDM and complete Clinical SAS alongwith job. With 1 year of experience in CDM and complete Clinical SAS cource certification you can land on a handsome salary.

  • @dirkfritzgerald552
    @dirkfritzgerald552 ปีที่แล้ว

    promo sm

  • @vasimkhatik8062
    @vasimkhatik8062 ปีที่แล้ว

    Keep sharing your valuable tips, learning a lot from you.😊

  • @Billi_Ghar
    @Billi_Ghar ปีที่แล้ว

    Only time will tell, whether this will be a boon or bane !!