Certificate Program in Conducting & Managing Bioequivalence & Bioavailability Studies

Cliniminds
Distance

Rs 20,000
+ VAT
You can also call the Study Centre
91302... More
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Important information

  • Certificate
  • Distance learning
  • Bhopal
  • Duration:
    6 Months
Description

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

Important information
Venues

Where and when

Starts Location
On request
Bhopal
Medical Director Cliniminds Unit of Tenet Health Edutech Pvt. Ltd. C-55, 1st Floor, Preet Vihar, Main Vikas Marg, 110092, Delhi, India
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Frequent Asked Questions

· Requirements

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.

Course programme

This is a continuing training / educational program designed to provide a practical knowledge
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

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