BioPharm International-12-01-2006

Columns and Departments

December 01, 2006

The prospect of any cost savings has been fueling efforts to establish a pathway for follow-on biopharmaceuticals.

Offshoring to China has captured the imagination of Western managers seeking to reduce operating costs. What is the best approach?

Vagueness in the ICH Q2A and Q2B guidelines necessitates effective protocol design and data analysis. For specificity (detection in the presence of interfering substances), the goal is statistical differences with meaningful implications on assay performance. Linearity (results directly proportional to concentration of analyte in the sample) is typically demonstrated via least squares regression. Accuracy (difference between measured and true values) usually is presented as a percent of nominal. Precision analysis is vital because it supports claims of accuracy and linearity. A well-designed experiment and statistically relevant methods will facilitate method validation in accordance with ICH guidelines.

Columns and Departments

December 01, 2006

There are 72 maladies for which human patients have received some benefit from adult stem cell interventions.

Columns and Departments

December 01, 2006

In various races in the November elections, voters supported stem cell research. Now, will they prepared to fund it?

Recently, 22 vice presidents of biopharmaceutical operations met in Boston to develop the first operational roadmap for their industry. This special executive-level consortium was organized to discuss two key questions.

A key to bolstering FDA and its mission is securing balanced and consistent funding.

Conducting an analysis of the 4 Ms-man, machine, methods, and materials-enables companies to identify the true root causes of deviations.