Manufacturers Struggle with Breakthrough Drug Development
March 16, 2014 - By: Jill Wechsler BioPharm International

Accelerated testing and production create challenges in documenting product quality.

Biopharmace

Determining Criticality–Process Parameters and Quality Attribut


March 15, 2014 - By: Mark Mitchell BioPharm International
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validat

FDA and EMA Extend QbD Parallel-Assessment Pilot Program
March 15, 2014 - BioPharm International

FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parall

Design of Experiments for Analytical Method Development and Valid


March 15, 2014 - By: Thomas A. Little, PhD BioPharm International

Design of experiment is a powerful development tool for method characterization and method validation.


Report: Branded Biopharms Most Exposed to Biosimilar Competition
March 8, 2014 - BioPharm International

In a new report on the global biosimilar drug

EMA Collaborates with HTA Assessment Networks
February 22, 2014 - By: Sean Milmo BioPharm International High technology assessments are having an impact on biosimilars development in Europe.


Gaining access to

The Affordable Care Act's Impact on Innovation in Biopharma
February 22, 2014 - By: Jill E. Sackman, PhD, Rita E. Numerof, PhD, Michael Abrams BioPharm International

The biopharmaceutical industry contempla

Outsourcing Trends in Biopharmaceutical Manufacturing
February 18, 2014 - By: Eric Langer PHARMACEUTICAL TECHNOLOGY

Brazil Emerges as Global Biopharm Collaborator
February 6, 2014 - By: Hellen Berger BioPharm International Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator

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The phar

Early Communication with Regulators is Essential for SMEs
January 27, 2014 - by: Sean Milmo, Pharmaceutical Technology With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regul

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