Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Emerging Therapies Drive Analytical Advancements

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Analyzing Exabytes

Effective analytics will eliminate failures, deviations, and non-conformances.

Quality in, Quality Out

June 02, 2009

A book guides readers through the regulatory requirements for computerized quality systems.

Initial Solvent Screening of Carbamazepine, Cimetidine, and Phenylbutazone: Part 2 of 2

June 02, 2009

The authors describe the importance of a rapid and an abbreviated screening strategy in initial solvent screening. This article contains bonus online-exclusive material.

Truth and Transparency

June 02, 2009

Misleading the public about their investments-be it money or medicine-is unacceptable.

Beneath the Surface

June 02, 2009

It can take a lot of work to make sure nothing happens.

Charting a Pathway to Follow-On Biologics

June 02, 2009

Debates about science, manufacturing, and European regulations will shape the approval process for follow-on biologics in the United States.

Pharmaceutical Technology Europe

Why we need mass serialization — now!

June 01, 2009

Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.

Company and People Notes: Pfizer Forms Licensing Agreements; Malvinder Mohan Singh Steps Down at Ranbaxy, More...

May 28, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Johnson & Johnson acquires Cougar Biotechnology; NIH launches program for rare and neglected diseases; PPD restructures leadership positions; more...

Company and People Notes: Teva and Lonza Joint Venture Approved; Novartis CFO to Retire; More...

May 21, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Oxford BioTherapeutics forms drug development pact with GSK; Avila Therapeutics names CEO; more...

FDA Issues First Sentinel Initiative Project Report: Statistical Methods

May 14, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

The first project report on FDA's Sentinel website, discusses the evaluation of existing methods for safety signal identification.

FDA Requests Largest-Ever Budget Increase

May 14, 2009

ePT--the Electronic Newsletter of Pharmaceutical Technology

On May 7, 2009, as part of the President's fiscal year (FY) 2010 budget, the US Food and Drug Administration requested a budget of $3.2 billion, which is 19% more than the agency's current budget.