Clinical Trials | Different Phase of Clinical Trial | What is Clinical Trial | Clinical Pharmacology
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- Опубликовано: 11 сен 2024
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Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioural research studies on human participants are designed to answer specific questions about biomedical or behavioural interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.
Phase 0- Phase 0 trials are optional first-in-human trials. Single subtherapeutic doses of the study drug or treatment are given to a small number of subjects (typically 10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs
Phase 01- Often the first-in-man trials. Testing within a small group of people (typically 20-80) to evaluate the safety, determine safe dosage ranges, and begin to identify side effects. A drug's side effects could be subtle or long term, or may only happen with a few people, so phase 1 trials are not expected to identify all side effects.
Phase 02- Testing with a larger group of people (typically 100-300) to determine the efficacy and to further evaluate its safety. The gradual increase in test group size allows for the evocation of less-common side effects.
Phase 03- Testing with large groups of people (typically 1,000-3,000) to confirm its efficacy, evaluate its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.
Phase IV- Postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use. As such, they are ongoing during the drug's lifetime of active medical use
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This topic i studied last yr but understood today🙏
Good. Thank you for feedback
I always used to think that the subject pharmacy is very hard to understand but when I started attending your lectures u made so easy sir... Thank you very much.
Great. Wish you all the best
U HAVE DESCRIBED ALL THE PHASES OF CLINICAL TRIALS VERY NICELY THANKS YOU
I am b-pharm graudate trying to get in clinical research for the last 1 year in mumbai. Now i understand clinical research is only for masters degree holder. ☹️
Very informative pointers for beginners sir. Thank you.
I am an Electrical Engineer, just started watching this video to gain some basic knowledge on clinical trial
But I seriously gained something more than basics
Thanks for your lucid & simple explanation.
Great work
Thanks & Regards
Great. Happy to know that i could give you some knowledge. Thank you for your feedback sir.
Great 😂😂
What all we wanted ..
We found everything in ur video sir .
Ur videos makes harder topic to understand in easier way.
Thankuh sir😊
Great. Thank you so much for your feedback
You have these lectures slides?
Great explanation sir
And the white bord informations r very good way for presenting topic
Gayatri Sharma Thank you so much
THANKS YOU U HAVE DESCRIBED ALL THE PHASES OF CLINICAL TRIALS
Thank you sir you are explaining in a very easy manner.
My pleasure
Sir ji thanks for the video. Your teaching style is very understandable and simple.
Thank you
Easy to understand n all concepts are clear
Thank you so much
THANK YOU SOOOO MUCH SIR !♥️
SARAY CONCEPTS CLEAR HOGAYE HAIN.
YOU'RE THE BEST TEACHER🌸🌸🌸
Thank you so much for your kind support and feedback
Came across this video and its very lucidly explained. Correction- its not congress but council for both ICH and ICMR.
Thank you. Yes you are right. I did mistake
Thank you sr because I watch your video my concepts is very clear,its very helpful for Gpad preparation
Thank you. All the best
Rohit pawar bro it's gpat not gpad
Sir AAP bahot achha padhate he ..me aapka savi vedio dekhta hun .. dekhne me savi samajh me aajata he. .achha lagta he ..thank u sir
Thank you so much
thank you so much sir... this video give me proper knowledge about drug development process... it will be very beneficial for my upcomming exam .... love from Nepal
Thank you so much
I clearly understand this topic this is so helpful thank you sir your videos provide best knowledge about our pharmacy field and for GPAT
Thank you so much.
Awesome thankyou sir
Today is my exam nd your video is helpfull to me.
mayur chauhan most welcome. All the best
Sir ka video bahut bahut help ful rahata hai iss leye mai add skip nahi karta hun ..ap log bhi skip mat kiya kijaey ❌
Thank you so much. Bahut support hoga isse hame
Wow what a quote at the starting of the video...thanku so much sir
Thank you so much sir for explanation ❤
Very simplied yet thorough knowledge of the given topic . excellent presentation sir
Great explaination sir , your command on topic is amazing , thank you sir for providing this systematic and useful information for us
Thank you. Its my pleasure
Very useful sir thanku so much
please make video on NDCT Rules 2019
Such video needed in times of such pendamic for awareness
Thank you
Really good brief about Clinical Research.Thank you for making awareness about job ready career
Thank you for your feedback
Your explanation is best....
Thank you
Doing great work sir 🥰🙏
Thank you
Best information and clear and clean.. well explained ♥️😍..thank u so much sir.😍♥️
Most welcome. Happy that you got satisfied.
Thnq sir 🙏🙏
In the whole video all information is pretty good. But there is some corrections in video ICMR/ICH "C" stands for Council not Congress.
Yes. I have admitted my mistake eralier. Here again i am seeking sorry for that mistake.
This is so much informative thank you very much sir
Welcome
Great explanation Sir 🙏
Thank you
Sir how much time does it take for clinical trials for non invasive electronic medical device
excellent presentation kindly share with me clinical trail related more videos to clear the concept.Thanku
Thank you so much sir🙏🙏🙏🙏🙏🙏🙏🙏.
🙏. Sir plz upload SAR on dictionary channel
Very helpful video thanq so much sir
My pleasure
Thankyou sir this video help me a lot
Thank u sir i hve my exam tommorow plz pray for me hope i write well
Sir please upload other subject like medicinal chemistry, physical pharmaceutics, organic chemistry sir
Bhai Muja Aapse AKkam Haa
aap Khase Hoo
Thank you sir 🙏🤗
Very helpful thank you sir ..
Thank you
Nice concept Sir 👍 keep it up 💪
Amaresh Kumar Gautam Thank you
Good explanation
Thanks
Thank you
Sir aapne Short me bahut achha samjhaya hai
Thank you
Well done sir 👍
Thank you
Tq you so much sir...bohoth ache sey samaj ah Gaya..lots of love 💞
Very well explained....Thank-you sir!
saumya upadhyay Thank you so much for valuable feedback.
Thank you so much sir .. please make more videos, i strongly support you sir
Thank you. We have finished all most all
Topics of cology.
Sir, I request you to upload videos in english, since I dont know Hindi and it would be a great help sir.
Well structured content.Kindly tell something about protocol writing at different phases!
Thank you and really sorry this videos are as per 4 sem syllabus.
Thanks 🙏
Nice explanation sir. Thank u so much . It was really a good presentation about diff phases .
excellent sir
Thank you
sir your videos are very helpful for us
Thanks alot
Very well explained sir.Thanks for sharing
Most welcome
Thnx sir for giving us... Information about this topic...
Welcome
Really very nice sir
Sir u r great
Thank you
It was really helpful
easy steps fish care Thank you
ICMR stands for Indian Council of Medical Research (ICMR). You mentioned C as Congress
C= conference
Sorry jay ji. Galti se ho gaya
It's ok ☺☺
Thank you so much sir ❣️
My pleasure
Nice video sir very useful in time of corona
Thank you
It's really helpful to all
Sir plz ek sequence me video ko playlist me upload kriye . searching me prob ATI h....I like to see your videos in detail
Playlist bana hua hai. Go to pharmacology 1 and 2 and then 3
Very nyc video sir
Thanks and welcome
Good topic sir 👌 thanks for video
Pratap Bachhar Welcome. Its my pleasure.
Very nice information sir👌👌👌👌
Thank you
Thank you
Very nice sir..
Good information sir very well explained
Thank you
Nice teaching 👌, thanks sir
Sir I can not crack GPAT 2019 , nd I'm too much upset till now and lost my self-confidence ; can you please upload a video on how can I get over from this situation nd how can I again start preparation to get a good rank in GPAT 2020 ,?
Great respect .
Thank you Patel sir
Thanks for sharing
My pleasure
Thanks sir ji
Welcome
Nice information
Thank you
Thank you. It was very useful.
Can you tell me what is the difference between study period and intake period, for a particular disease area?
First i will find out cause of disease,
Then how much time to spread of disease and how to prevent it..
this should be in more detail.. but good explanation
kumar gourav Thank you. Yes it should be. But this topic is included as a sub topic and thats why it is short
Sir very informative video 🙏
sikander jit singh thank you so much
Very nice sir
No any dought
Thank you so much
Sir aap k lectures bht achay hain..please stages of drug developement pe video bnayein complete...formulation , up scaling?
Thank you. Thats not in syllabus of cology right now
Thankyou sir for this helpful video
My pleasure
God bless you sir
sir please make a vedio on investigational new drug
Very nice
Thank you
Sir please give a lacture on the topic clinical research
Great Job sir
Thank you
Sir please make vedio on schizophernia diseases
Good one ....
Sir can u plz explain data above data or metadata..
snehal rewatkar Thank you. Currently fixd on syllabus.
@@solutionpharmacy So will you explain it or not sir
snehal rewatkar Sorry sir. Not possible at the moment
@@solutionpharmacy Then when it can be possible ?
Plz do it when ever it 'll be possible for u with all topic of cdm ...
As early as possible ...tq
snehal rewatkar I am not sure. Running 5 sem then 6 sem. In which sem of B Pharmacy this topic is specified
Wowwww❤️ thank you so much sir🙏
Thank you
Rules & regulations for animal ad human experiment .....sir ye question b krwa dijiye
Sir I have a question....It is generally said that bactericidal and bacteriostatic drugs are antagonistic to each other but why some combinations such as cefexime and azithromycin are used
They are not antagonists
Tq sir
Prashant Shivhare Welcome
Sir biostatistics pe video banaiye please
Great effort
manmeet singh thank you
Clinical trails for tooth regeneration and repair through biological way in future.
please make a video on it
Great Sir. Thank you, Sir
My pleasure