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Pharmaceutical Clinical Bioequivalence Study (BA/BE)

Clinical Bioequivalence Study
5.0
5.0/5
(2 reviews)
20 students
Created by

9.3

CourseMarks Score®

9.9

Freshness

9.6

Feedback

7.7

Content

Platform: Udemy
Price: $11.99
Video: 1h 38m
Language: English
Next start: On Demand

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Detailed Analysis

CourseMarks Score®

9.3 / 10

CourseMarks Score® helps students to find the best classes. We aggregate 18 factors, including freshness, student feedback and content diversity.

Freshness Score

9.9 / 10
This course was last updated on 3/2021.

Course content can become outdated quite quickly. After analysing 71,530 courses, we found that the highest rated courses are updated every year. If a course has not been updated for more than 2 years, you should carefully evaluate the course before enrolling.

Student Feedback

9.6 / 10
We analyzed factors such as the rating (5.0/5) and the ratio between the number of reviews and the number of students, which is a great signal of student commitment.

New courses are hard to evaluate because there are no or just a few student ratings, but Student Feedback Score helps you find great courses even with fewer reviews.

Content Score

7.7 / 10
Video Score: 7.8 / 10
The course includes 1h 38m video content. Courses with more videos usually have a higher average rating. We have found that the sweet spot is 16 hours of video, which is long enough to teach a topic comprehensively, but not overwhelming. Courses over 16 hours of video gets the maximum score.
The average video length is 2 hours 02 minutes of 52 Pharmacy courses on Udemy.
Detail Score: 9.7 / 10

The top online course contains a detailed description of the course, what you will learn and also a detailed description about the instructor.

Extra Content Score: 5.5 / 10

Tests, exercises, articles and other resources help students to better understand and deepen their understanding of the topic.

This course contains:

0 article.
0 resource.
0 exercise.
0 test.

Table of contents

Description

Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs.
Note: If you are paying more than 5k INR or $15 for private institute/academy then you are in loss.
Please compare the course description and amount you are paying for such course.
Bioavailability & Bioequivalence
Bioavailability (BA) is defined as the rate and extent to which the unchanged active substance is absorbed and becomes available in the systemic circulation. Understanding bioavailability is essential during drug development as it is one of the fundamental properties of drug formulation.
Information on bioavailability is also used to determine bioequivalence (BE) when submitting a generic dossier.
Through interactive sessions and multiple case studies, this course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting. Once completed you will have a solid understanding of bioavailability, supporting you in drug development.
You will also have the confidence to develop and implement your own bioequivalence studies to ensure speedy generic approval.
The course will also examine key aspects of biowaivers such as the regulatory hurdles, types of biowaivers and data needed so you can save money and time with fast biowaiver applications.

Benefits of Course:
After taking this course, students will be able to specify the design of a new drug or new device study with the goal of establishing whether the new protocol is statistically equivalent to an existing therapy.
You will learn how to design a study in accordance with regulatory requirements, as well as appropriate methods for analyzing data.
You will be able to fit statistical models to dose-response data with the goal of quantifying a reliable relationship between drug dosage and average patient response.
•Basic concepts for Bioequivalence study
•Bioavailability & bioequivalence
•Types of Study Designs
•How Generic medicine becomes Bioequivalent with Branded Medicines
•Criteria and considerations for BA/BE Study
•Conduct PK analysis of time-concentration data
•Conduct dose-response analysis
•Specify bioequivalence designs for parallel and crossover designs
•Review actual clinical trials and identify end point, question of interest, statistical method used
Who Should Take This Course
Diploma Pharmacy Students/Professor
Pharmacy Students
Pharmaceutical researcher, Investor, Doctors
Medical Professional
Analysts responsible for designing, implementing or analyzing clinical trials.

You will learn

✓ Bioequivalence Study
✓ Bioavailability
✓ Generic Medicine Vs Branded Medicine
✓ Bioequivalence study design
✓ FDA Approval for Generics
✓ Pharmacokinetics & Pharmacodynamics
✓ Distinguish between Generics Vs Branded Medicines
✓ Why generic medicines are cost effective

Requirements

• Pharmacy Background
• Pharma Profession
• Medical background required
• Freshers & Experienced Professionals
• Pharma Graduates / Post-Graduates
• Research & Development

This course is for

• Pharmacy
• Pharmacy Graduates Students
• Pharmacy PG Diploma
• Medical Students
• Pharma Research Scientist
• Pharma Professional

How much does the Pharmaceutical Clinical Bioequivalence Study (BA/BE) course cost? Is it worth it?

The course costs $11.99. And currently there is a 40% discount on the original price of the course, which was $19.99. So you save $8 if you enroll the course now.
The average price is $15.8 of 52 Pharmacy courses. So this course is 24% cheaper than the average Pharmacy course on Udemy.

Does the Pharmaceutical Clinical Bioequivalence Study (BA/BE) course have a money back guarantee or refund policy?

YES, Pharmaceutical Clinical Bioequivalence Study (BA/BE) has a 30-day money back guarantee. The 30-day refund policy is designed to allow students to study without risk.

Are there any SCHOLARSHIPS for this course?

Currently we could not find a scholarship for the Pharmaceutical Clinical Bioequivalence Study (BA/BE) course, but there is a $8 discount from the original price ($19.99). So the current price is just $11.99.

Who is the instructor? Is Mahesh Pratapwar a SCAM or a TRUSTED instructor?

Mahesh Pratapwar has created 5 courses that got 110 reviews which are generally positive. Mahesh Pratapwar has taught 8,029 students and received a 3.1 average review out of 110 reviews. Depending on the information available, Mahesh Pratapwar is a TRUSTED instructor.
Regulatory Professional
I Am Mahesh Pratapwar.I am Pharma Professional, Complying with Regulatory Specifications for Pharmaceutical products.I have completed M.Pharm (P.Ceutics).Work experience more than 5 years in Pharma Industry.Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. … Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.

9.3

CourseMarks Score®

9.9

Freshness

9.6

Feedback

7.7

Content

Platform: Udemy
Price: $11.99
Video: 1h 38m
Language: English
Next start: On Demand

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