Drug Discovery Phases =| Introduction to Drug Development | Drug Discovery | Drug Development

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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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Sir, thank You for your lecture on this specific topic, please reply my question sir, Is Drug Discovery process is same as Design New Drugs process? Please Reply

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Very useful .

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Sir pls make a video on drug response rekationship

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That will be cover under practical session.

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Sir what are the chronological development of pharmaceutical process?

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Sir jo clinical trials me lab work or discoveries karte hai..unko kya bolte hai??...and uski eligibility kya hai?

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Hlo sir Preformulation studies preclinical kaa part hoti h yaaa phir iske baad hoti h...????

[@solutionpharmacy]

Uske baad ka hai. Jab clinical trial me pass ho jaaega to uski tayari hoti hai

[@jhansimunuru8200]

Sir Is drug design and drug discovery are same...please answer my question sir.. Then also kindly tell me the difference of both..and please suggest the class video content to learn about the topic drug design..please sir ...🙏

[@solutionpharmacy]

Munuru Jhansi no both are diff. (But in few case it looks like same) Discovery means somthing new is to be find where design is to make it as per need like - BA, Duration of action etc

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Conceptual stage ke ..kitne stages hai ??and ye preclinical s age wale step kon s stage m ata hai

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Good sir

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Sir please make the video that include question which are important for semster examination 🙏

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Kishan Shukla We have already uploaded important question from unit 01 and 02. Please find in our channel.

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Protein threading explain sir

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use english, it will add up to more viewers and it will be benefit to them to acquire the knowledge

[@solutionpharmacy]

charles michael Thank you so much for your valuable suggestion sir. Actually I have started this channel to support those students who are not good in english, i believe that getting the point in hindi is more imp so that they may write accordingly. Although your suggestion is good and i will look on it. Thanks.

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Please visit our new channel for upcoming lectures in English. Link- kzbin.info

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What Is Theoretical Drug Design ? Sir Is Rational Drug Design And Theoretical Drug Design is Same ?

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Sorry for that and thanks alot for such comliment

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@@solutionpharmacy sr pls drug k bare m puri jankari dijiye......kon si dose kb kam aati h ...for meternity .

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Sorry we dont include dose and duration

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Sir what Steps are required for Theoritical Formulation and Development of a Tablet..?! An Ingredient that is already Available but if someone wants to modify it then what are the steps required?

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SAR and random trial

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Piyush Singhal I wish i could suggest you but i have no idea about med chem. When i will know i will surely inform you.

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Kulkarni

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Sir please sir help Points missing hain STANDARD DOSE REGULATED DOSE TARGET LEVEL DOSE TITRATED DOSE Explained please sir

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We dont teach chemistry. Sorry

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@@majidali4896 they teach micriobiology pharmacognosy and pharmacology

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Sir Ji upgrade your self now four phases are running in for clinical trials

[@solutionpharmacy]

Dear sir thank you for your suggestion. Sure i will upgrade my information. But i would like to provide you 01 information. Its a deep concept. In this video i have talked about the phases before any drug come to market not total phase so here 03 phase is right. Please watch this one, here you will find 04 phase in total phases- kzbin.info/www/bejne/fqeYiKRmf96KgKs

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Please go to youtube setting and increase play qualit to HD

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sir i think you forgot to expain point no 4 phamaceutical formulation.

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That might be

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Its belong to pharmacology

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Mrenal Kanty Ray No making new medicine is work of Research department. Although he may work along with them and share his or her idea.

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Its not blur. How can we upload blur vidoe ? Its your network issue. Our all videos are of HD

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Nahi

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Use English to benefit general audience pliz

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Agree. But there are many channel in english.

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KZbin ke setting me playback quality ko increase kariye

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Facebook se pdf notes kaise download kare

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Welcome