Pharmaceutical Engineering & Drug Delivery

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...

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),...

CMC Reviewer Expectations for ANDAs Using QbD Approaches

Oct 18, 2011
Robert L. Iser
There has been an increase in science and risk-based approaches under the Quality by Design paradigm in new drug submissions to the FDA. There are particular challenges for generic drug manufacturers with respect to using QbD approaches, especially with more complex dosage forms, such as modified...

Metabolic Flux Analysis of Escherichia Coli MG1655 Under Octanoic Acid Stress

Oct 17, 2011
Yanfen Fu
Metabolic engineering has evolved to the point of fulfilling the dream of having our industrial chemicals produced renewably. Carboxylic acids (e.g., short chain fatty acids (SCFAs) such as octanoic acid (C8)) are one such chemical intermediate that can be produced with Escherichia coli engineered...

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...

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