COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.
Journal Title: International Journal of Drug Regulatory Affairs - Year 2015, Vol 3, Issue 3
Abstract
To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The Paper covers different kind of Biowaiver approaches and the criteria for the applicability of BCS based Biowaivers in the different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of Biowaiver approaches as well as for requirements of Biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based Biowaiver concept as one of the three main guidance documents (USFDA, EMA, WHO) or a combination of specific requirements.
Authors and Affiliations
Patel Jimi, Mehta Priti, Kothari Vaishali
Keywords
Related Articles
- EP ID EP339230
- DOI -
- Views 90
- Downloads 0
ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY: A REVOLUTIONIZED LC TECHNIQUE
High Performance Liquid Chromatography (HPLC) is a major technique for qualitative and quantitative drug analysis. More than 90% of drugs prescribed in official pharmacopoeias are being analyzed HPLC. HPLC analyzes the d...
PHARMACY PROFESSION IN GUJARAT: AN OVERVIEW
Pharmacy is the health profession that links the health science with chemical science and it is charged with ensuring the safe and effective use of pharmaceutical drugs. Gujarat has been one of the pioneer States in Indi...
REGULATORY ENVIRONMENT FOR MEDICAL DEVICES IN NEW ZEALAND
Medical Devices are one of the most important health intervention tools available for the prevention, diagnosis and treatment of diseases and for patient rehabilitation. Although the Medical Devices market in the New Zea...
A PRAGMATIC WAY TO SUSTAIN IN GENERIC PHARMA ENVIRONMENT: PLCM THROUGH REGULATORY STRATEGIES
Most thoughtful way to sustain in this competitive highly regulated Pharma generic industry environment is depended on understanding the concept of the product life cycle management (PLCM). Fact is a very less number of...
DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE
In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality, safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has...