CMC Section EU IMPD

Understanding Leaching from Stoppers into Lyophilized Drugs

Steven Zdravkovic examines options for extractable and leachable studies to evaluate leaching from primary packaging into lyophilized drugs.

BioPharm International  (February 2019)

The CMC section of an EU IMPD: Considerations for US sponsors

John Watkins discusses investigational medicinal product dossier requirements for US sponsors planning to submit clinical trial applications in EU member states.

Regulatory Rapporteur  (February 2019)

Proactive regulatory intelligence communication

Kirsten Messmer outlines regulatory intelligence communication approaches for medium to large companies and highlights the advantages and disadvantages of each.

Regulatory Focus  (January 2019)

Regulatory reforms in Australia – Improving access to new medicines

Peter Lynch discusses regulatory changes in Australia that are designed to lead to earlier access to lifesaving medicines for patients.

Regulatory Rapporteur  (January 2019)

Osteoporosis: Addressing the unmet need

Rose Blackburne and Davide Garrisi provide an overview of the osteoporosis landscape and the associated regulatory environment.

American Pharmaceutical Review  (December 2018)

Improving Clinical Trial Awareness and Recruitment

Acurian’s Ryan McFarlane discusses how sophisticated patient recruitment organizations are helping to meet increasing enrollment needs.

PM360  (December 2018)

PPD beefing up biologics lab services in Ireland

PPD expanding its biologics capabilities in Athlone to include cell and gene therapy analytical testing.

BioProcess International   (December 2018)

PPD Expands GMP Lab Testing Capabilities

PPD Laboratories is focused on providing cutting-edge gene and cell therapy analytical testing services and capabilities around the world.

Contract Pharma  (December 2018)

PPD adds biologics testing to GMP lineup in Ireland

The company’s goal is to offer the same extensive biologic, gene and cell therapy portfolio to clients in both Europe and North America.

Outsourcing-Pharma  (December 2018)

The impact of vortexing on the particle-size distribution of pharmaceuticals

Greg Maj, Jeff Driscoll, Eric Olson and Jonathon report on a study that compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size distribution.

Pharmaceutical Technology  (November 2018)

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