Preclinical Trial |Introduction to Preclinical Trial | Preclinical Study | Drug Discovery Phases

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Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes pre-clinical research on microorganisms and animals, filing for regulatory statutes, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.
(1) The first step in the drug development process involves discovery work. This is where drug development companies choose a molecule, such as a gene or protein, to target with a drug.
(2) The next step in the drug development process is preclinical testing, which in itself is divided into two subcomponents: in vitro and in vivo testing. In vitro testing examines the drug molecules' interactions in test tubes and within the lab setting.
(3) The third step involves submitting an Investigational New Drug Application to the FDA prior to beginning human clinical trials.
(4)Clinical trials
Phase I trials, usually in healthy volunteers, determine safety and dosing.
Phase II trials are used to get an initial reading of efficacy and further explore safety in small numbers of patients having the disease targeted by the NCE.
Phase III trials are large, pivotal trials to determine safety and efficacy in sufficiently large numbers of patients with the targeted disease. If safety and efficacy are adequately proved, clinical testing may stop at this step and the NCE advances to the new drug application (NDA) stage.
Phase IV trials are post-approval trials that are sometimes a condition attached by the FDA, also called post-market surveillance studies.
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[@MayankSingh-wj2bt]

bohot achi lagi Animation sir

[@panorama85]

Love and respect from Bangladesh sir🇧🇩

[@solutionpharmacy]

Thank you so much

[@raviroshan5266]

Good effort by you sir

[@solutionpharmacy]

Thank you

[@kamleshyadav6285]

Nice lecture sir..

[@solutionpharmacy]

Thank you

[@MANISHKUMAR-rz5fv]

Thank you sir

[@solutionpharmacy]

My pleasur e

[@mouryashweta6392]

Thank you so much sir

[@solutionpharmacy]

My pleasure

[@arindamdas463]

Sir plz upload OECD guidelines vedio

[@Shubham-xh5tw]

bhot badiya

[@solutionpharmacy]

Thank you

[@prashantraghav4134]

Sir kiya apke pass pharmacological screening method ki book available h kya

[@shubhangipatil9771]

Sir i request you to upload last chapter of new syllabus

[@dikshasahu1124]

Molecular docking screening ecplain sir plz

[@ramrajayadav7201]

Mast video sir

[@solutionpharmacy]

Ramraja Yadav Thank you

[@riyaali7982]

Wow 😍😍😍😍😍😍

[@solutionpharmacy]

Thank you

[@suchimaithani2538]

Ye konsi playlist h ??? Apke channel ki

[@dileepbodige4904]

Gd evng sir, please upload screening methods in pharmacology

[@solutionpharmacy]

Ok

[@munmibaruah3705]

Sir I m a student of physiotherapy 3rd semester. I start to learn pharmacology from your video bt now I confused from where I started ? What is the basic video .. because every playlist have more than 100 video ...which one is for 3 nd semester physiotherapy students? Because pharmacology subject is new for us

[@solutionpharmacy]

I am not aware of physiotherapy. Search as per your syllabus and make your own playlist. That will help you

[@manoharnayak374]

Is non clinical drug testing is different from pre clinical drug testing or same??

[@solutionpharmacy]

Manohar Nayak Non clinical means ?

[@bts_rollercosterlifepurplearmy]

Animation is good but i suggest u to add voice with instructions, i think that helps to understand more easily and effectively....

[@solutionpharmacy]

The animation is separately available with audio

[@bts_rollercosterlifepurplearmy]

@@solutionpharmacy Ok i will consider that .....

[@somnathgharge9386]

Sir hair loss baldness treatment k bare me latest clinical trial ka jra bataiye pl

[@solutionpharmacy]

Sorry iska to idea nahi hai

[@diksha9288]

Sir if non-pregnant animals should not be used.then Jo pregnant women ko drug di jati h wo kese test hogi

[@solutionpharmacy]

Diksha Dhanotia Thats a v good question. Once in a time i have asked a scientist a same question. He said to me- Nothing is safe for a pregnant woman, its less toxic or more toxic. Means we have to relay on less toxic substance. And no experimental model allow us to make a trial on preg. Woman. But personaly i think there should be some alternative for it.

[@i_mermaid]

Sir can you please make a whatsapp group for sharing notes and pdf bcoz sir all students don't use facebook.

[@solutionpharmacy]

Sorry i am not able to handle whatsapp. We have to teach all days and there is member limitation in group

[@i_mermaid]

@@solutionpharmacy okay sir🥺

[@_nomi.sarpanch_]

From india 🇮🇳 2024

[@mr.pranjalnarkhede3735]

sir if pregnant animals can"t be used then how the drugs contraindicated in pregnancy {humans} are determined ?

[@solutionpharmacy]

When inwas student inhave asked the same question to my teacher butbhe did not answered but now i have answer. A single basic rule - All drug are treated as not safe in pregnancy. Then theoritically as per their profile like - water soluble of Fat soluble we assume that this may not safe or bit safe. Not 100% safe.

[@mr.pranjalnarkhede3735]

@@solutionpharmacythanku.. but only solubility factor sufficient? Can i have more information sir please🙏

[@solutionpharmacy]

@@mr.pranjalnarkhede3735 i have given what i knew. You may search online too

[@ranjana_kumari268]

Sir how can I download PDF of this chapter. Plzzz reply as early as u can

[@solutionpharmacy]

Really sorry sir. Pdf of this topic is not available

[@ranjana_kumari268]

@@solutionpharmacy but u have tell in this video that their is PDF on fb of drug discovery

[@solutionpharmacy]

I said that there is pdf available of different pharmacology topic not all topic sir. Sorry for the trouble you have faced.

[@ranjana_kumari268]

@@solutionpharmacy no it's okkk sir

[@swarnapravamishra4981]

What's app group kon sa he

[@solutionpharmacy]

We dont have whatsaap group.

[@mubeensheik4280]

Please explain in English sir

[@maheshmatcha9901]

Please explain in English,

[@solutionpharmacy]

Please visit our new channel for pharmacology lectures in English (Started From 01/12/2020). Link- kzbin.info

[@sakshikasana9625]

sir, the only problem is that your videos are way tooo long. try to make short videos please.

[@solutionpharmacy]

What is the length of your class in college ?? At present i am making videos of 4O mints. I will make videos of desirable length. You may leave at any point.

[@paichemistry9885]

Badly explain

[@solutionpharmacy]

So sorry. I will try to learn please help me how can i improve sir

[@sabyasachinanda1973]

@@solutionpharmacy you are absolutely amazing sir, you explain well I understand very nicely... Keep it up... (Students rate a teacher's/lecture's explanation) non of others

[@solutionpharmacy]

@@sabyasachinanda1973 thank you so much for your kind support and love.

[@solutionpharmacy]

Prof. Sandip sir please share any of your video sir i an exited to learn from you.

[@shubhangipadole9322]

Thank you sir

[@solutionpharmacy]

My pleasure