courses details
Course Description
BIOEQUIVALENCE REGULATORY COURSE
March 1st, 2019 Webinar: Introduction to Bioequivalence Studies and Regulations
This webinar’s objective is to introduce the basics of bioequivalence studies, how it is use in generic drug development and approval. Additionally, a brief introduction of global regulations related to bioequivalence will be reviewed. The attendee will leave this webinar with a basic understanding of how bioequivalence studies are the cornerstone of ensuring that generic drug products are safe and as effective as the brand drug products they are based on.
Outline of Topics
Principles of Bioequivalence
Regulatory authority on bioequivalence (BE)
Definitions of key Bioequivalence terms
Why BE studies are requested
Approaches to determine BE
Designing a Bioequivalence study
March 13th, 2019 Webinar: Introduction to Bioanalytical Method Validation and Bioanalysis
This webinar’s objective is to introduce the topic of bioanalytical method validation and discussing how validation is important in ensuring that the data generated from bioequivalence study samples (Bioanalysis) are valid and representative of product (both generic and brand) performance in vivo. The attendee will leave the webinar with a basic understanding of importance role of bioanalytical method validation and bioanalysis have on the evaluation of samples from bioequivalence studies.
Outline of Topics
Small Molecule Quantitation
Method Development
Method Validation
Validation criteria
Subject Sample Analysis
March 27th, 2019 Webinar: Introduction to Dissolution testing
This webinar’s objective is to introduce the dissolution test and highlight its important role during generic drug approval, and after drug approval. A brief introduction of how dissolution testing is used as part of the waiver of bioequivalence studies will be presented. The attendee will leave the webinar with a basic understanding of dissolution testing and its key role in generic drug development and approval.
Outline of Topics
Dissolution Background
USP General Chapters <711>, <724>, <1092>
Instrumentation: USP Apparatus 1, 2, 3, 4, 5, 6, 7
Dissolution testing set up
Role of dissolution testing pre-approval
Regional Recommendations
Post-approval/Variations changes
Introduction to Biowaivers
BIOEQUIVALENCE STUDIES REVIEW AND ASSESSMENT TRAINING
Draft Outline of Topics: Face to Face Training
Day 1:
Review of the Global Regulation of Generic Drugs
Global Harmonization of Bioequivalence regulations
Day 2:
Simulation of Bioequivalence Study
Review of Bioequivalence basics
BE Study Consideration for various dosage forms
Day 3:
Bioanalytical Method Validation
Bioanalysis
Statistical analysis
Day 4:
Regulatory Aspects of Dissolution
Biowaivers
BCS based Biowaiver
Day 5:
BE Study Documentation and Review
Common deficiencies
Case studies
About the Faculty
Dr. Loice Kikwai
Managing Partner / Ex-US FDA, Consultant/Educator Saudi FDA, US Pharmacopeia & CePAT. Unique expertise in registration of devices and medicinal products
Loice Kikwai is the managing parter at LCK Pharmaceutical Consulting. She has twelve years experience in the field of pharmaceutical drug regulation and standardization. Recently, Dr. Kikwai has served as a consultant and educator of global pharmaceutical best practices at the Saudi FDA and at US Pharmacopeia – Ghana: Center for Pharmaceutical Advancement and Training (CePAT). Prior to that, Dr.Kikwai worked at the US FDA, Office of Generic Drugs as a bioequivalence dossier assessor and at US Pharmacopeia as a scientist setting standards for Dissolution Apparatus and Franz Diffusion Apparatus.
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