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Statistical Applications in Clinical Research and Pharmaceuticals

This course covers the applications of statistics in pharmaceutical Product development (Design of Experiments/Quality by Design) & clinical research, fundamental aspects of statistical analysis including types of data, choosing appropriate choice of statistical tools based on type of data etc.

Beginner 5(8 Ratings) 211 Students enrolled English
Created by Dr D Prabakaran
Last updated Sat, 06-May-2023
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Course overview

This course covers the applications of statistics in pharmaceutical Product development (Design of Experiments/Quality by Design) & clinical research, fundamental aspects of statistical analysis including types of data, choosing appropriate choice of statistical tools based on type of data etc. Application of different statistical methods including sample size determination, Hypothesis testing, regression analysis, Analysis of Variance etc. are provided. The course also provides an overview of randomization procedures, clinical trial designs & contents of Statistical Analysis Plan (SAP). The statistical approaches used for different types of bioequivalence studies are also discussed. The content and methodology of our courses are structured to complement self-directed learning. As such, participants will be able to review course material at their own pace, however, should complete the course within the allocated time provided for the course.

What will i learn?

  • Overview of Statistical Applications in Clinical Research/Pharma
  • Types of Data
  • Commonly Used Statistical Analysis Methods
  • Hypothesis Testing
  • Sample Size Determination
  • Randomization Procedures
  • Clinical Trial Designs
  • Statistical Analysis Plan
  • Statistical Approaches in Bioequivalence Studies
  • Statistical Approaches in BE of Narrow Therapeutic Index Drugs
  • Statistical Approaches in BE of Highly Variable Drugs
Requirements
  • This course is open to all individuals, especially the graduating individuals/Freshers in Pharmacy/Life science/Science domain, Engineering & Technology, Arts & Languages Domain, Commerce & Economics and Trainees seeking to obtain a general overview of the fundamentals of statistical applications, especially from life science/pharmaceutical research industry including clinical research/pharma research/bioequivalence industries.
Curriculum for this course
15 Lessons 03:19:46 Hours
General Module - Pharmaceutical Industry Scope and Opportunities
1 Lessons 00:36:53 Hours
  • General Module - Pharmaceutical Industry Scope and Opportunities
    Preview 00:36:53
Module 1 - Statistics in Pharmaceutical Research & Development
1 Lessons 00:08:03 Hours
  • Module 1 - Statistics in Pharmaceutical Research & Development
    Preview 00:08:03
Module 2 - Basic Statistical Terminologies
1 Lessons 00:07:21 Hours
  • Module 2 - Basic Statistical Terminologies
    00:07:21
Module 3 - Types of Data & Statistical Analysis Methods
1 Lessons 00:27:01 Hours
  • Module 3 - Types of Data & Statistical Analysis Methods
    00:27:01
Module 4 - Hypothesis Testing
1 Lessons 00:10:12 Hours
  • Module 4 - Hypothesis Testing
    00:10:12
Module 5 - Analysis of Variance (ANOVA)
1 Lessons 00:13:33 Hours
  • Module 5 - Analysis of Variance (ANOVA)
    00:13:33
Module 6 - Sample Size
1 Lessons 00:15:09 Hours
  • Module 6 - Sample Size
    00:15:09
Module 7 - Randomization
1 Lessons 00:09:12 Hours
  • Module 7 - Randomization
    00:09:12
Module 8 - Clinical Trial Designs
1 Lessons 00:22:37 Hours
  • Module 8 - Clinical Trial Designs
    00:22:37
Module 9 - Statistical Analysis Plan (SAP)
1 Lessons 00:06:29 Hours
  • Module 9 - Statistical Analysis Plan (SAP)
    00:06:29
Module 10 - Statistical Concept in Bioequivalence
1 Lessons 00:19:04 Hours
  • Module 10 - Statistical Concept in Bioequivalence
    00:19:04
Module 11 - Statistics in Bioequivalence of Highly Variable Drug (HVD)
1 Lessons 00:08:49 Hours
  • Module 11 - Statistics in Bioequivalence of Highly Variable Drug (HVD)
    00:08:49
Module 12 - Statistics in Bioequivalence of Narrow therapeutic Index (NTI) Drug
1 Lessons 00:05:23 Hours
  • Module 12 - Statistics in Bioequivalence of Narrow therapeutic Index (NTI) Drug
    00:05:23
Quiz
1 Lessons 00:10:00 Hours
  • Quiz - Multiple Choice Questions
    0:10:00
Live Interaction
1 Lessons 00:00:00 Hours
  • Live Interaction
    Preview .
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About instructor

Dr D Prabakaran

13 Reviews | 234 Students | 3 Courses
Clinical Research Bioequivalence Pharmaceutical Product Development Regulatory Affairs Analytical Development
Dr. Prabakaran is doctorate in pharmaceutical sciences from Dr. Hari Singh Gour University, Sagar, MP, and he started his career as formulation scientist in 2004. In 2006, he mov...
Student feedback
5
8 Reviews
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Reviews

  • Siva Prakash Jalakam
    Excellent Course to understand basics of statistics, various statistical terminology, study designs and regulatory requirements related to clinical research and pharmaceuticals
  • Kamalakkannan Mani
  • Ajithkumar B
    It’s useful for me
  • JUSTIN ABRAHAM
    Very useful
  • Alphy Lopes
    The session was very informative and concepts were explained in a manner so that they were easy to understand
  • Jay Nand
  • Babburi Sreerama Chandra Murthy
  • Triveni BAHEKAR
₹ 4999 ₹ 999
Includes: