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bioavailability bioequivalence ba be study training

Introduction

Who should attend

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About BA BE study

Bioavailability Bioequivalence (BABE) Study

This short orientation training provides fundamental understanding and requirements for conducting Bioavailability and Bioequivalence BA BE Study. Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of a generic version to its proprietary version of a drug or formulations of an innovator drug in different clinical trial phases. Here in this online course we carry out the design and analysis of bioavailability and bioequivalence studies.

It is important for pharmaceutical manufacturers to establish Bioavailability and Bioequivalence BA BE Study in compliance with current regulations is therefore critical to development of generic pharmaceutical products. Therefore, BA / BE  guidelines need to be followed as specified by the regulatory agency. And stability results should be incorporated in the drug dossier which in turn is submitted to the regulatory agency.

In these online self-paced modules, participants will be understanding about the requirements of the Bioavailability and Bioequivalence BA BE Study The course provides valuable insight on Bioavailability and Bioequivalence guidelines and how to conduct the BA BE study.

Training Snapshot

  • Course Code: RYD-094
  • Course Title: Fundamental Training in Bioavailability Bioequivalence (BA/BE) Study [Microlearning Course]
  • Nature of the course: Online micro learning course. So, course can be accessed online anywhere 24×7.
  • Duration: 3 days.
  • Course Certificate : Certificate will be provided at the end of the successful completion of the course.

Any body who wants to acquire competency regarding new drug development process, should attend the course.

Who should attend this course? 

  • This course is ideal for those who require detailed BA BE study understanding. For example, those working in Analytical Development, Analytical Chemistry, Stability Testing, Formulation Development, Regulatory Affairs, Pharmaceutical & Biopharmaceutical Production, Product Development, Technical Operations.
  • Fresher/Beginners, Those who want to make a career in drug regulatory or pharmaceutical products.
  • Moreover, this Bioavailability and Bioequivalence study will be ideal for BA/BE managers, R&D managers, Pharmacokinetics scientists, IVIVC specialists, Formulation managers, Solid dosage formulators, Regulatory affairs managers.
  • This course provides detailed understanding on Bioavailability and Bioequivalence (BA / BE) studies  which need to be adopted by the pharmaceutical producers. Hence, this course is ideal for the regulatory, QA/QC professions, or those who are handling drug dossiers for regulatory submission.
  • The course focuses on how to design a bioequivalence study.
  • Moreover, the course also provides a clear cut understanding of the statistical design needed to get regulatory approval.
  • Most importantly, the course connects the understanding of the dissolution data to pharmacokinetics, and the predictive power of the pilot studies.
  • The requirements for studies in fasting and fed state
  • Validation and compliance issues
  • What is the relationship between formulation and bioavailability?
  • What to look for when auditing a BA BE study house in terms of validation.
  • Insight on IVIVC.

BA/BE study

BA/BE studies is the short form of Bioavailability & Bioequivalence Studies. Bioequivalence is a term in pharmacokinetics. Bioequivalence assess the expected in vivo biological equivalence of generic version to its proprietary version of a drug or formulations of innovator drug in different clinical trial phases.

The study evaluates clinical differences in the bioavailability of two distinct drugs. These studies are conducted to assess the efficacy of a new drug product which may have a few different excipients or inactive ingredients.

Differences between BA and BE study

Bioavailability studies (BA studies) focus on determining the process and time frame by which a drug substance is released from the oral dosage form and moves to the site of action. On the other hand, bioequivalence studies focus on the performance of the drug product. BA and BE study usually involve comparisons of two drug products.

PK Studies

A pharmacokinetic (PK) study of a new drug involves taking several blood samples over a period of time from study participants to determine how the body handles the substance. These studies provide critical information about new drugs.

Section 1Fundamental Learning on BA BE study
Lecture 1PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 2Bioequivalence Study | Study design | Different types of BE Studies
Lecture 3Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 4Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 5Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 6Bioequivalence Study - Discussion - Dissolution Testing
Lecture 7Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 8IVIVC  - Basis | Importance | Case Based Determination of IVIVC 
Lecture 9Setting Dissolution Specification for Generic Products | Regulatory Expectations
Lecture 10Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 11Comparability of Biologics | Different Categories of Comparability | General Principles 
Lecture 12CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Section 2Generate Course Certification