Authors





Michael Morgen

Latest:

Selecting the Appropriate Technology for Oral Bioavailability Enhancement

Model-based formulation and technology selection methodologies facilitate rapid product development.





Mark Nachtigall, PhD

Latest:

Practical Approaches to Tech Transfer and Scale-up of Lyophilization Processes

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.


Shen Chen, PhD

Latest:

Practical Approaches to Tech Transfer and Scale-up of Lyophilization Processes

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.



Andy Cooper

Latest:

A QbD Method Development Approach for a Generic pMDI

Application for Sirdupla Uniformity of Delivered Dose Methodology












David Semin

Latest:

Evaluating Progress in Analytical Quality by Design

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.


Gunnar Kahlmeter

Latest:

What is Antibiotic Resistance?

The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.



Isochem

Latest:

Vitamin E TPGS for Drug Delivery Innovation

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Russell Madsen

Latest:

Unknown and Unknowable

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.


Sidney Backstrom

Latest:

The Quest for Cleanroom Flexibility

Contextualizing what type of flexibility is needed is paramount when considering cleanroom design.