Authors


Rita M. Steffenino

Latest:

Is Your Tablet Hard to Swallow? Guidance Addresses Drug Tablet Design

EMA and FDA guidance encourages design of drug products to improve patient compliance.


Heino Prinz

Latest:

Automated Visual Particle Inspection

This article discusses fully automatic inspection of glass and plastic containers and factors that affect particle detection rate. 


Anastasiya Zakhvatayeva

Latest:

How to Monitor HPMC Concentration Through Conductivity Measurement

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.


Maria Grazia De Angelis

Latest:

How to Monitor HPMC Concentration Through Conductivity Measurement

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.


Linda A. Herzog

Latest:

The Real Complexity of Excipient Composition

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.


Carlo De Carolis

Latest:

How to Monitor HPMC Concentration Through Conductivity Measurement

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.


Pietro Pirera

Latest:

How to Monitor HPMC Concentration Through Conductivity Measurement

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.


Alessandro Resta

Latest:

How to Monitor HPMC Concentration Through Conductivity Measurement

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.


Joseph Zeleznik

Latest:

Mitigating the Risk from Excipient Variability

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.


Catalent Pharma Solutions

Latest:

Nitrosamines, Elemental Impurities, Extractables, and Leachables: The Pharma Industry’s New Normal

Various impurities can infiltrate the container closure system in pharmaceutical manufacturing. Understanding nitrosamines, elemental impurities, extractables, and leachables can help ensure the safety of the final product.


John Yin

Latest:

The Role of Powder Characterization in Continuous Manufacturing

Experimental work on wet granulation demonstrates the use of dynamic powder characterization to support continuous processing for tablet manufacturing.


Patheon, a part of Thermo Fisher Scientific

Latest:

Does Your Clinical Trial Design Satisfy the Needs of Your Patients?

*** Live: Thursday, November 5, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET***At the center of every clinical trial is a patient awaiting treatment. Learn from the experts on how to design a decentralized clinical trial to improve patient recruitment and retention. ***On demand available after final airing until Nov. 5, 2021***



MilliporeSigma

Latest:

Filtration in Dissolution Testing: Improving Throughput and Reducing Variability

Wednesday, June 30, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST



Ascendia

Latest:

Long acting PLGA complex parenterals and IVIVC development

Webinar Date/Time: Wed, Mar 26, 2025 1:30 PM EDT


Clive Jones

Latest:

Maintaining Thermal Fluid Systems

Preventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.



Thu Truong

Latest:

Taking a Holistic Approach for Data Governance

As regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.


Ron George

Latest:

Taking a Holistic Approach for Data Governance

As regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.


James Davidson

Latest:

Taking a Holistic Approach for Data Governance

As regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.


Sharon Ayd

Latest:

Impact of Non-Compliance on the American Healthcare Consumer

GMP non-compliance can spill over and impact patient access to life-saving medications.


Sándor Kemény

Latest:

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.


Máté Mihalovits

Latest:

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.


James Schmid

Latest:

Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better

Traditional project decision-making is compared with a QbD approach.


Alex Wheeler

Latest:

Does Your Endotoxin Detection Method Ensure Patient Safety?

Understanding the relative strengths and weaknesses of different endotoxin test methods is crucial to maintaining quality and patient safety.


David Vodak

Latest:

Selecting the Appropriate Technology for Oral Bioavailability Enhancement

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


Michael Grass

Latest:

Evaluating Drug Substance–Drug Product Interplay Accelerates Development

Innovative approaches to drug screening—such as evaluation to identify the optimal solid state of a molecule and in-vitro characterization to establish the optimal solid state of a molecule and the ideal bioavailability-enhancing technology—can help drug developers meet accelerated development timelines while managing risk.


Scott Barnard

Latest:

The Value of LMS in Driving Effective Risk Mitigation Principles through QMS and QRM

Investing in a single source enterprise-wide LMS to fuel risk management and mitigation offers multi-dimensional return on investment.