Development

Articles

Dr. Ulrike Lemke, Head of Sterile Fill Finish at Recipharm, sat down with Grant Playter, associate editor, to discuss drug delivery forms.

Exploring Drug Storage, Drug Dosage, and the Supply Chain with Ulrike Lemke (DCAT Week)

These models are useful in predicting whether an unknown substance of abuse can permeate the BBB to produce effects predicted by the Public Health Assessment via Structural Evaluation (PHASE) approach.

New QSAR Model for Predicting Blood Brain Barrier Permeability

Editor of Pharmaceutical Technology Europe

Podcasts

In this episode, Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

Feliza Mirasol is the science editor for 

Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.

Catalent Licenses Bhami Research Laboratory Technology for Biologics Formulation Development

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

Influencing Change in Drug Delivery

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

Drug Solutions Podcast: Progressing Excipients Through Review

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Pharmacovigilance Risk Assessment Committee Meeting Highlights

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Opportunities and developments in particle engineering are providing developers with the tools to advance drug candidates successfully.

Putting a Spotlight on Particle Engineering

In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.

Formulation and Drug Delivery