Pharmaceutical Engineering & Drug Delivery

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...

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...

Building a Better Biofuel Production Platform

Oct 17, 2011
Stevan Albers
Building a Better Biofuel Production Platform: Engineering metabolic control techniques to control the photosynthetic cyanobacterium Synechocystis sp. PCC 6803 Stevan C. Albers 1 , Christie A.M. Peebles 1,2 1 Cell and Molecular Biology Graduate Program, 2 Department of Chemical and Biological...

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...

QbD - It's Not Just for Breakfast Anymore

Oct 16, 2011
Paul C. Collins
We are approaching the ten-year mark for the Quality by Design initiative in the pharmaceutical industry. Much has been accomplished and demonstrated, particularly with regard to enhanced understanding of processes and better definition of processing parameters such as CPPs. Design space has become...

Automation and Control of Drug-On-Demand Technology

Oct 16, 2011
Laura Hirshfield
After the implementation of initiatives such as PAT and QbD, there has been a drive towards efficient manufacturing in the pharmaceutical industry. The concept of "mini-manufacturing" of drugs, as opposed to mass production of drugs, has shown promise in this area. We describe one such "mini-...

Using QbD to Asses the Factors That Affect Stability and Packaging

Oct 16, 2011
Stephanie Krogmeier
Packaging is often the last step in drug product (DP) development; however packaging is extremely important in determining the marketability of a product. The ability to predict whether a product can be stored at room temperature early in development can affect how the drug is developed. In order...

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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