Ask the Regulatory Experts

Revised guidelines published by EMA and HMA update the rules on identification of commercially confidential information and personal data used in marketing authorization applications.

This episode is a compilation of comments taken from a series of interviews where experts are discussing how AI might impact the global bio/pharma industry in the future.

Emer Cooke, executive director of EMA, is encouraged by the competitiveness of the European pharmaceutical market.

In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry experts who recently exhibited at CPHI Milan.

Carrier-based formulations for dry powder inhalers are carefully designed to transport extremely small particles into the lungs. Jet milling can be used to micronize these particles, with both high and low shear mixing processes used to formulate mixtures capable of carrying the fine API particles into the deep lung. This paper looks at the requirements for pulmonary delivery via carrier-based inhaled powder formulations, and how jet milling can be used to manufacture effective and stable materials for these formulations

The companies will use Orexo’s powder-based drug delivery technology to develop mucosal vaccines in an inhaled formulation.