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Pharma Learn
Индия
Добавлен 25 фев 2021
Learn Pharmacy !!!!
Contract Research Organization (CRO)
Clinical Research Organizations (CROs) are pivotal entities in the pharmaceutical and biotech industries, offering specialized services throughout the drug development process. They provide expertise in various areas such as clinical trials, data management, regulatory compliance, and pharmacovigilance. These organizations streamline research processes, enhance and maintain regulatory standards, ultimately facilitating faster and more cost-effective drug development.
Check out my other video in the playlist:
-molecular pharmaceutics: ruclips.net/p/PLje_c_Rko79LIvgdSsq_9kL1RDRMelqSC
-novel drug delivery system: ruclips.net/p/PLje_c_Rko79L98-9wqFAmC7_6QY4gjmiw
-Regulatory affair: ruclips.net/p/...
Check out my other video in the playlist:
-molecular pharmaceutics: ruclips.net/p/PLje_c_Rko79LIvgdSsq_9kL1RDRMelqSC
-novel drug delivery system: ruclips.net/p/PLje_c_Rko79L98-9wqFAmC7_6QY4gjmiw
-Regulatory affair: ruclips.net/p/...
Просмотров: 2 513
Видео
Indian regulatory requirement for labelling of cosmetics
Просмотров 1 тыс.Год назад
CONTENTS: 1.DEFINITION OF COSMETICS PRODUCT AS PER INDIAN REGULATION 2.DRUG AND COSMETICS ACT 1940 & RULE 1945 LABELLING REQUIREMENTS FOR COSMETICS. 3. SUMMARY check out my other video in playlist: -molecular pharmaceutics: ruclips.net/p/PLje_c_Rko79LIvgdSsq_9kL1RDRMelqSC -novel drug delivery system: ruclips.net/p/PLje_c_Rko79L98-9wqFAmC7_6QY4gjmiw -Regulatory affair: ruclips.net/p/PLje_c_Rko79...
Events and biological processes involved in drug delivery | Targeted drug delivery system (Part-2 )
Просмотров 1,5 тыс.2 года назад
Content in Events and biological processes involved in drug delivery:- -Cellular uptake and processing -Transport across the epithelial barrier -Extravasation -Lymphatic uptake check out my other video in playlist: -molecular pharmaceutics: ruclips.net/p/PLje_c_Rko79LIvgdSsq_9kL1RDRMelqSC -novel drug delivery system: ruclips.net/p/PLje_c_Rko79L98-9wqFAmC7_6QY4gjmiw -Regulatory affair: ruclips.n...
Targeted drug delivery system |Part-1| Introduction and concept
Просмотров 1,3 тыс.2 года назад
TARGETED DRUG DELIVERY SYSTEM CONTENTS: -Introduction, -Goal, -Why Targeted drug delivery system is required? -Concept of Targeted drug delivery system, -Advantages and -Disadvantages of Targeted drug delivery system. other videos in Regulatory Affairs: Investigational New Drug(IND)- ruclips.net/video/bBIx6Ny_QRQ/видео.html Abbreviated New Drug Application (ANDA)- ruclips.net/video/DRSR5Qqj13c/...
NEW DRUG APPLICATION | REGULATORY AFFAIR
Просмотров 12 тыс.2 года назад
NEW DRUG APPLICATION: The NDA contains all of the information and data that the FDA requires for market approval of a drug. A new drug application (NDA) includes enough information for the FDA to determine whether the new drug is safe and effective; whether the drug’s benefits outweigh its risks; whether the proposed drug label (package insert) is appropriate; and whether the drug manufacturing...
Abbreviated New Drug Application (ANDA) | Drug Regulatory Affairs
Просмотров 19 тыс.2 года назад
An ANDA is a request to the Food and Drug Administration (FDA) to manufacture and market a generic drug in the United States. The ANDA does not require the applicant to conduct clinical trials. An ANDA-approved drug must be bioequivalent to the brand-name drug. If an ANDA is approved, it is listed in the Orange Book as an FDA-approved medicine. orange book: ruclips.net/video/-WG VFKIdo/видео.ht...
Investigational New Drug(IND)
Просмотров 22 тыс.3 года назад
learning objective: 1)Introduction of Investigational new drug 2)what is IND? 3) Types if IND 4)IND chart
CODE OF FEDERAL REGULATION
Просмотров 11 тыс.3 года назад
LEARNING OBJECTIVE: CODE OF FEDERAL REGULATION 1)DEFINITION, 2)LIST OF CFR, 3)E-CFR, 4)TITLE-21.
what is orange book?
Просмотров 14 тыс.3 года назад
learning objective: 1)what is orange book? 2)content of orange book. 3)electronic orange book.
HATCH WAXMAN ACT
Просмотров 9 тыс.3 года назад
LEARNING OBJECTIVE HATCH WAXMAN ACT 1)INTRODUCTION. 2)APPROVAL OF GENERIC DRUG. 2)OBJECTIVE OF ACT. 3)PATENT CERTIFICATION. 4)PARA-IV PATENT CHALLENGE.
BRANDED DRUG VS GENERIC DRUG
Просмотров 1,6 тыс.3 года назад
LEARNING OBJECTIVE: 1)WHAT IS BRANDED DRUG? 2)WHAT IS GENERIC DRUG? 3)COMPARISON BETWEEN BRANDED AND GENERIC DRUG 4)WHY BRANDED IS EXPENSIVE THAN GENERIC DRUG?
PHARMACEUTICAL COMPANY DISTRIBUTION RECORD
Просмотров 1,2 тыс.3 года назад
LEARNING OBJECTIVE: DISTRIBUTION RECORD 1.INTRODUCTION 2.DEFINITION 3.CONTENTS 4.IMPORTANTS
DRUG MASTER FILE
Просмотров 6 тыс.3 года назад
LEARNING OBJECTIVE: DRUG MASTER FILE(DMF) 1)Definition 2)Requirement 3)Types of DMF
MASTER FORMULA RECORD
Просмотров 6 тыс.3 года назад
MASTER FORMULA RECORD CONTENTS: 1)INTRODUCTION. 2)OTHER NAMES. 3)DEFINITION. 4)CONTENT OF MASTER FORMULA RECORD. 5)PROCEDURE OF MASTER FORMULA RECORED. 6)CONCLUSION.
PREFORMULATION
Просмотров 1073 года назад
LEARNING OJECTIVE: UNDERSTAND ABOUT PREFORMULATION AND IMPORTANCE OF PREFORMULATION.
POLYMER- PROPERTIES, ADVANTAGES AND ITS APPLICATION | PART-2| B-PHARM | NOVEL DRUG DELIVERY SYSTEM
Просмотров 9 тыс.3 года назад
POLYMER- PROPERTIES, ADVANTAGES AND ITS APPLICATION | PART-2| B-PHARM | NOVEL DRUG DELIVERY SYSTEM
POLYMER AND IT'S CLASSIFICATION | PART-1 | B-PHARM | NOVEL DRUG DELIVERY SYSTEM
Просмотров 4 тыс.3 года назад
POLYMER AND IT'S CLASSIFICATION | PART-1 | B-PHARM | NOVEL DRUG DELIVERY SYSTEM
Transport of substances across cell membranes
Просмотров 1,6 тыс.3 года назад
Transport of substances across cell membranes
🎉🎉🎉
Thanks for the valuable information
Your voice is so sweet
I think this voice is computers generated... Am I right?????
Easy way to prepare note
Very informative! Thanks for posting
Very easy explanation mam. Thank you so much🎉
Thank you so much
Why you're reading only why?
Hello Madam, Video is very informative. Only one question how often is orange book hard copy published?
The Orange Book is continuously updated electronically, and new editions are not published in hard copy on a set schedule like some printed publications. The information in the Orange Book is updated in two ways-on its website and in print publications that are also available as downloadable PDFs. Website updates occur on a daily, semi-monthly, monthly, and annual basis. Print updates occur on a monthly and annual basis. It is usually updated with new drug approvals, withdrawals, therapeutic equivalence evaluations, and related information as they occur.
Wow
Very good information mam🎉
Batch formula ka bhi video kr lete saath me 😒
Helpful 👍
Tq ng madem
exemptions??
Superb
@Pharma Learn - Can you please share the presentation to us if possible
@Pharma Learn thanks a lot for the wonderful video on ANDA
Awesome and thanks
Great
Very nice please keep uploading
All videos are very informative and best thing in all videos is I will gets all points clearificatio.
Very nice 👍 easy to understand
Whether we need to study pink,orange, purple, yellow book for fso exam
So helpful mam we want more videos on m pharm (pharmaceutics) Regulator affairs subject
Thank you for this video 🙏
Glad it was helpful!
Well explained
Thanks for the explanation 😊 nice video
Super
super super super mam.... excellent explanation mam. please keep on doing such vedios mam
Excellent
Extraordinary explanation mam
Thanks a lot
Super presentation and explanation mam.. Thank you so much for a wonderful vedio of info... Please do some more vedios mam
Sure 👍
Very east to understand
explain in detail...
Super. 👌👌👌
❤️🙌🏻
Samjh ni lagi ap explain krdia Kee plzz
Very easy to understand. 📒📒📒
Keep watching
Y u reading ppt explain it 😭😑😔
Andhulo antha clarity ga vundhi.. explain cheyyadaniki ame ledu enkaa
What's the features of Orange drug?? For this Question what we have to write please reply mam??
The Orange Book contain information about: (1) approved prescription drug products with therapeutic equivalence evaluations; (2) approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs; (3) drug products with approval under Section 505 of the FD&C Act administered by the Center for Biologics Evaluation and Research; and (4) a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn from sale for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.
@@pharmalearn9407 thank you so much
Sis viedo on common technical document and electronic common technical document
thank you for your comment. surely i will upload video on CTD.
Tooo slow 🙄
Very good
Thanks
Nice information ☺️
More videos wanted
Good
Super
Good