Authors


Sherry Ku

Latest:

Solutol HS15 as a Novel Excipient

The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.


Yves Robin

Latest:

Using Tocophersolan for Drug Delivery

Tocophersolan or TPGS was developed 60 years ago as a water-soluble form of vitamin E. The author gives an overview of TPGS, including its interesting properties, examples found in the literature, and a brief summary of the regulatory status and marketed formulations.






Neal Wesley

Latest:

Mitigating Personnel Risks

Training cleanroom operators can be one of the most challenging aspects to maintaining cleanroom conditions. PTE speaks to Neal Wesley, technical director at SCM Pharma, to find out the best practices for training and ensuring continued compliance.


Salvatore Mercuri, PhD

Latest:

Enhancing Dissolution of Poorly Soluble Drugs through Jet-Milling

The authors discuss a novel particle engineering technology based on mechano-chemical activation.







Kevin J. McGlue

Latest:

Significant Changes in the 2014 IPEC Significant Change Guide

A revision and modernization of the IPEC Significant Change Guide incorporates concepts of risk assessment.


Wanis Kabbaj

Latest:

Considering Cold Chain Needs

Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.


Dirk Van Peteghem

Latest:

Considering Cold Chain Needs

Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.


News Update

Latest:

Novartis Announces EU Approval of Lung Cancer Drug

Novartis announces that its lung cancer drug, Zykadia, gained European Union approval.


Jim J. Zhang, Ph.D.

Latest:

Shifting Biopharma Strategies Shape Outsourcing Market

Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.






Mettler Toledo

Latest:

White paper: Effects of X-ray Inspection of Pharmaceutical Products

This paper answers a major concern of manufacturers: Do x-rays affect the quality and efficacy of a drug during product inspection?


Fouad Atouf, PhD

Latest:

Managing Risk for Biomanufacturing Raw Materials

USP is developing new guidelines to help organizations prioritize risk and ensure raw material quality.


Dale Schmidt, M.S.

Latest:

USP Publishes Monoclonal Antibody Guidelines

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.


Lance Smallshaw

Latest:

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.


Carlos W. Lee

Latest:

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.


Helmut Rockstroh

Latest:

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.


John Glennon

Latest:

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.


Samuel Powell

Latest:

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.