Search form

Pharmaceutical Engineering & Drug Delivery

Flowchart Methodology Utilizing Validated Process Models as the Foundation for a Quality-by-Design (QbD)-Based Approach for Pharmaceutical Unit Operations: Example Case Studies

Nov 10, 2009
Lisa Graham
A model-based process development methodology is described which uses a Quality by Design (QbD) approach to establish a manufacturing design space. A flowchart methodology is described that illustrates how to rationally step through process development, using fundamental and engineering models and...

Update on QbD Implementation: An FDA Perspective

Nov 8, 2009
Christine Moore
Quality by Design (QbD) is a science and risk based approach for pharmaceutical process development and manufacturing that begins with first defining clinically relevant product attributes and then designing and implementing a process to consistently deliver quality product. Some key aspects of QbD...

Establishing Appropriate Particle Size Specifications for Solid Oral Dosage Forms

Nov 8, 2009
Zhigang Sun
Control of particle size distribution of pharmaceutical powders is critical in the manufacture of solid oral dosage forms due to significant impact of particle size on the safety and efficacy of the drug product. As shown in many publications, particle sizes of powders have profound influences on...

Drug Product Quality by Design: An Industrial Perspective

Nov 8, 2009
Mary T. am Ende
The regulatory quality guidances (Q8 – Q10) have set the expectation to develop pharmaceutical products based on a comprehensive quality by design approach. These expectations have permeated our industry as the new gold standard. Pharmaceutical development and commercialization programs are now...

Application of QbD Principles to Analytical Methods

Nov 8, 2009
Jackson Pellett
The same QbD Principles applied to the design of manufacturing processes are applicable to the design of analytical methodology. QbD elements such as understanding the science behind the methods, and improving method reliability by identifying and controlling sources of variability are key. This...

SBE Update: Drug Delivery and Chemical/Biological Engineering

March
2013
SBE Special Section
June Wispelwey
Although you might not associate drug delivery with chemical engineering, the principles of chemical engineering — such as mass and energy balances, transport phenomena, reaction kinetics, and particle technology — are intimately involved in drug...

Introduction to Drug Delivery Technology

March
2013
SBE Special Section
John T. Santini, Jr.
Drugs can be administered by many routes, yet all emerging drug delivery technologies aim to improve drug efficacy, minimize side effects, and reduce the burden of care for patients and physicians.

Engineering Biodegradable Nanoparticles for Drug and Gene Delivery

March
2013
SBE Special Section
Junwei Zhang, W. Mark Saltzman
Engineered nanoparticles can deliver therapeutic agents to specifically targeted cells and then release those agents in a precisely controlled manner. Improved pharmacokinetic properties, reduced toxicity, and the ability to cross biological barriers are some of the key benefits of this approach.

The Blood-Brain Barrier and Drug Delivery

March
2013
SBE Special Section
William Olbricht
To maintain favorable conditions in the brain, the blood-brain barrier limits mass transfer across brain tissue. However, it also restricts the systemic delivery of compounds to treat neurological disorders. Several treatment alternatives to bypass...

Bioactive Devices: Uniting Form with Function

March
2013
SBE Special Section
Sujata Bhatia
Bioactive implants that combine a medical device with one or more biologic therapeutic agents show promise for the targeted treatment of complex medical conditions. Implantable medical devices, such as stents, grafts, and joint replacements, are...

Pages

Subscribe to Pharmaceutical Engineering & Drug Delivery