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.
Suitability - Who should attend?
For professionals working in clinical drug development who formulate drugs. It is also a good course for those who work in QA in generic companies. Regulators would be interested due to BE data being used in variation applications.
Outcome / Qualification etc.
- Understand the fundamentals of bioavailability, bioequivalence and biowaivers
- Develop strategies for testing highly variable drugs and design studies for different types of formulation
- Assess the regulations in the EU, US, Russia, Brasil, China and Japan for bioequivalence studies to gain a global perspective and maintain compliance
- Determine when a BA/BE study is obligatory
- Examine bioanalytical method validation and requirements in the US and EU
- Learn to interpret biowaiver regulations in the US and EU and meet compliance
- Identify the various BA/BE protocol studies that are used
- Learn to calculate pharmacokinetic parameters on various types of studies and formulations
- Evaluating the risk associated with submitting a biowaiver
Training Course Content
Introduction and definitions
- What is bioavailability and bioequivalence?
- The concept of bioavailability and bioequivalence
- Examining when a bioavailability or bioequivalence study is mandatory
- Biowaiver: an in vivo surrogate
Evaluate the types of protocol studies used
- Gain a critical understanding of the protocol studies used depending on the type of drug and formulation
- Study protocol: key points for single dose, steady-state, fasted and fed studies
- Establishing methods to tackle highly variable drugs: repeated design and scale average bioequivalence
- Designing studies dependent on the type of formulation: IR, SR, DR, multiphasic, etc.
- Analysing the difference between an experimental and pivotal bioequivalence study
Examine examples of the following Bioequivalence studies
- Multi-dose, steady-state
- Classical cross over
- Two-step studies
- Replicated design
Summary of Bioanalysis
- Examining the bioanalytical method
- Requirements: FDA vs EMA
- Validation and the key points requested
- Specific points
- Incurred examples
- Matrix effect
- Managing the sampling schedule
- Parameters to be submitted depending on the type offormulation and studies
- Single dose: Cmax / Tmax/AUC 0-t/ 0-72h/ 0-infinity/partial AUC
- Steady state: Cmin/ fluctuation Index(FI)/ AUC/ Cmax
Statistical points and analysis
- Practical solutions to apply statistical analysis
- Number of subjects
- Log transformation why
- ANOVA: residual variance
- 90% confidence interval
- Period, sequence effect
- Repeated design
- Two-step design
Examples of specific cases
- Drop out, exclusion, “Blind review”
- Endogenous compound
- Fixed-dose combination
- Analysis of metabolites
- Composition of meal
- Examining the effects of subject position: standing/lying/sitting
- Special population
- Study in non-healthy volunteers
- Multi-dose example
Regulations and requirements for a Bioequivalence study: A global perspective
- The extent of global harmonisation
- Legal requirements in specific countries and regions
- Data prior BE study
- How to submit a Bioequivalence study
- Assessing the risk linked with BA/BE studies
- Dissolution data required
- Biowaver concept
- Guidance on the regulations and requirements
- How to interpret the regulations
- FDA vs EMA
- Examining the types of Biowaiver
- Self-evident Biowavers
- Locally Acting Locally Applied
- BCS based Biowaivers
- Strength Biowaver
- IVIVC based Biowaivers
- Understanding the risk when submitting a biowaiver
- What data needs to be submitted?
- Post-approval changes
Reporting: Overview of key points
- Focus on the main items to be reported
- Special cases of Biowaivers
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
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PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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