Pharmaceutical Clinical Bioequivalence Study (BA/BE) Course
Pharmaceutical Clinical Bioequivalence Study (BA/BE) Course, available at $34.99, has an average rating of 3.45, with 12 lectures, based on 34 reviews, and has 2473 subscribers.
You will learn about 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 Pharma Clinical studies This course is ideal for individuals who are Pharmacy or Pharmacy Graduates Students or Pharmacy PG Diploma or Medical Students or Pharma Research Scientist or Pharma Professional or Formulator or Pharma Investors or BA/BE sponsors It is particularly useful for Pharmacy or Pharmacy Graduates Students or Pharmacy PG Diploma or Medical Students or Pharma Research Scientist or Pharma Professional or Formulator or Pharma Investors or BA/BE sponsors.
Enroll now: Pharmaceutical Clinical Bioequivalence Study (BA/BE) Course
Summary
Title: Pharmaceutical Clinical Bioequivalence Study (BA/BE) Course
Price: $34.99
Average Rating: 3.45
Number of Lectures: 12
Number of Published Lectures: 12
Number of Curriculum Items: 13
Number of Published Curriculum Objects: 12
Original Price: ₹1,199
Quality Status: approved
Status: Live
What 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
- Pharma Clinical studies
Who Should Attend
- Pharmacy
- Pharmacy Graduates Students
- Pharmacy PG Diploma
- Medical Students
- Pharma Research Scientist
- Pharma Professional
- Formulator
- Pharma Investors
- BA/BE sponsors
Target Audiences
- Pharmacy
- Pharmacy Graduates Students
- Pharmacy PG Diploma
- Medical Students
- Pharma Research Scientist
- Pharma Professional
- Formulator
- Pharma Investors
- BA/BE sponsors
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.
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.
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Basic concepts for Bioequivalence study
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Bioavailability & bioequivalence
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Types of Study Designs
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How Generic medicine becomes Bioequivalent with Branded Medicines
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Criteria and considerations for BA/BE Study
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Conduct PK analysis of time-concentration data
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Conduct dose-response analysis
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Specify bioequivalence designs for parallel and crossover designs
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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.
Course Curriculum
Chapter 1: Course Overview
Lecture 1: Course Overview
Chapter 2: Introduction
Lecture 1: Introduction Part I
Lecture 2: Introduction Part II
Chapter 3: Pharmacokinetcs & Pharmacodynamics Concept
Lecture 1: Pharmacokinetics
Lecture 2: First Pass Effect (First pass Metabolism)
Chapter 4: Bioavailability & Bioequivalence
Lecture 1: Bioequivalence Overview
Lecture 2: Bioequivalence Basic Concept
Lecture 3: Bioequivalence Study
Chapter 5: GCP (Good Clinical Practices)
Lecture 1: Good Clinical Practices
Chapter 6: Rules and Protocols
Lecture 1: IRB (Investigational Review Board or ethics Committee)
Lecture 2: ICF (Inform Consent Form)
Chapter 7: Congratulations & Thank you
Lecture 1: Congratulations & Thank you
Instructors
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Mahesh Pratapwar
Pharmaceutical R&D/Regulatory Professional
Rating Distribution
- 1 stars: 2 votes
- 2 stars: 3 votes
- 3 stars: 5 votes
- 4 stars: 9 votes
- 5 stars: 15 votes
Frequently Asked Questions
How long do I have access to the course materials?
You can view and review the lecture materials indefinitely, like an on-demand channel.
Can I take my courses with me wherever I go?
Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!
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