Development

Articles

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FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence

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

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

Putting a Spotlight on Particle Engineering

Podcasts

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

Drug Solutions Podcast: Novel Excipients in Drug Development

Meg Rivers is the former senior editor for 

One company reaches beyond traditionally-conceived male contraceptives with Vasalgel, a reversible hydrogel injectable. 

The Next Generation of Male Contraceptives

An expert from Aptamer Group reveals the potential of Optimers (a type of aptamer) in the realm of drug delivery, including its targeting capabilities, scalability, and key differences between Optimers and antibody-drug conjugates. 

Drug Solutions Podcast: Drug Delivery Systems: Optimer’s Therapeutic Targeting and Scaling Capabilities vs. ADCs

External expertise is beneficial in helping companies select the right tools at the right stages of development to ensure success.

Adopting Smart Development Strategies

There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.

Reformulating Success

Some of the greatest advancements in drug delivery are related to disposable delivery devices, vaccine adjuvants, and wearable pumps, according to Nicholas W. Warne of Pfizer.

The Future of Drug Delivery for Biopharmaceuticals

It is possible to overcome some of the limitations of traditional dosage forms by employing alternative drug delivery formulation strategies.

Formulation and Drug Delivery