Pharmaceutical Engineering & Drug Delivery

QbD for Generic MR Drug Products

Oct 18, 2011
Yue (Helen) Teng
The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug products. This is based principally upon a regulatory paradigm that requires pharmaceutically equivalent drug products containing the same active ingredient, dosage form, and strength (among other things),...

Mechanistic Investigation of Drug Release From Asymmetric Membrane Tablets

Oct 18, 2011
Mary T. am Ende
An asymmetric membrane (AM) tablet was developed for a soluble model compound to study the in vitro drug release mechanisms in challenge conditions, including osmotic gradients, concentration gradients, and under potential coating failure modes. Porous, semipermable membrane integrity may be...

Quality by Design for Generic Drugs

Oct 17, 2011
Yingxu Peng
To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed mock QbD examples for immediate release (IR) and modified release (MR) dosage forms. This presentation will provide insight into OGD’s current...

FDA Perspective On QbD for Analytical Methods

Oct 17, 2011
Elaine Morefield
QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement. QbD provides new opportunities and modern tools to utilize in analytical research and development. ICH guidelines and implementation strategies focused mainly on formulation and manufacturing design and...

QUALITY by Design (QBD), Biopharmaceutical Manufacture

Oct 17, 2011
Kurt Brorson
In the biopharmaceutical industry, consistently manufacturing a safe and high quality protein drug substance can be challenging. Recently, a regulatory structure supporting Quality by Design (QbD) for pharmaceuticals and biopharmaceuticals has been described in International Conference on...

A QbD Approach to Improve Tablet Coating Uniformity

Oct 17, 2011
Atul Dubey
A combination of analytical and statistical methods is used to improve a tablet coating process guided by quality by design principles. A solid dosage form product was found to intermittently exhibit bad taste. A suspected cause was the variability in coating thickness which could lead to the...

QbD Principles for Packaging Design and Stability: A Regulatory Perspective

Oct 16, 2011
Sharmista Chatterjee
Quality by Design (QbD) is a science and risk based approach for pharmaceutical manufacturing and development. Enhanced product understanding gained from following a QbD based approach, is increasingly being used to select packaging design parameters and to determine optimum storage conditions. The...

Science-Based Stability and Packaging Development Under the Umbrella of QbD

Oct 16, 2011
Rey Chern
Abstract Science-Based Stability and Packaging Development Under The Umbrella of QbD Rey T Chern Global Pharmaceutical Commercialization Merck Sharp & Dohme A systematic approach for characterization of product stability risks, selection of primary packages and utilization of first-principle...

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