Certificate Program in Conducting & Managing Bioequivalence & Bioavailability Studies
Certificate
Online
Description
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Type
Certificate
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Methodology
Online
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Location
Bhopal
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Duration
6 Months
Course Objectives. Distinguish between bioequivalence and bioavailability. Understanding the management and conduct of bioequivalence and bioavailability studies. Understand how factors related to the dosage form and patient variables affect drug stability, dissolution capacity, and. absorption properties. Recognize problems that arise with bioequivalence and generic substitution. Learn which
Facilities
Location
Start date
Start date
About this course
MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate
Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry,
Microbiology, Biotechnology and all professionals working with Pharmaceutical companies,
CROs and hospitals.
Reviews
Course programme
for the clinical research professionals, potential staff for the BA/BE centers or CROs, other
pharmaceutical industry professionals and fresh science graduates & post graduates including
sales and marketing personnel and the students of pharmacy and other life science stream. The
program would cover:
Introduction to Clinical Research & Phases in Clinical Research
Principles of Good Clinical Practices - ICH GCP
Ethical Considerations in Clinical Trials
Drug Discovery & Development
Sponsor/Investigator Responsibilities
Sponsor Responsibilities
Investigator Responsibilities
Ethics Committees & Institutional Review Board
Clinical Trial Design
Protocol Design
CRF Design
Informed Consent Process & Documentation
Current Scenario of Clinical Research
Introduction to Major Pharma Regulatory Authorities and The Guidelines
IND & ANDA Investigational New Drug Application
Introduction to BA/BE and Phase-I Study
Types of BE Studies
Designing and Conducting BA/BE Studies
Conduct & Management of BA/BE Studies
Certificate Program in Conducting & Managing Bioequivalence & Bioavailability Studies