Topic

Richard K. Burdick is principal of Burdick Statistical Consulting and Professor Emeritus of Statistics at Arizona State University.

Articles

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study. 

Comparability in Accelerated or Stressed Stability Studies Using a Quality Range

The agency’s safety committee found no sufficient evidence of causal relationship between the antibiotic doxycycline and the risk of suicide or suicidal thoughts.

No Causal Link Between Doxycycline and Suicide, Says EMA Safety Committee 

Cheryl Barton is director of PharmaVision, 

The European Commission has developed a roadmap aimed at reversing the rising trend of cancer across the European Union. 

Advancing the Precision Oncology Agenda in Europe

Feliza Mirasol is the science editor for 

EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

Exosomes Field Advances with Milestones Achieved by EXO Biologics and ExoXpert

A new platform allowing market authorization holders to report drug shortages has gone live. 

EMA Announces Drug Monitoring Platform

Nicholas Saraceno is editor at Pharmaceutical Commerce.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

FDA Grants Approval to Kedrion to Produce PLGD-1 Therapeutic at Bolognana Plant

The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.

Pii Boosts Prefilled Syringe Capabilities with $3.6 Million Investment

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

EMA’s CHMP Gives Positive Opinion for Use of Lecanemab in Early Alzheimer’s Disease

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months. 

Quality Systems