Formulation and Drug Delivery

Mylan Partners with Theravance to Develop an Investigational Treatment for COPD

February 03, 2015

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

Obama Seeks Drug Pricing Authority, Shortened Data Exclusivity Period for Biologics

February 02, 2015

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

Ligand-Binding Assays and the Determination of Biosimilarity

February 02, 2015

Ligand-binding assays are fundamental to characterizing biosimilars.

Labeling of Biosimilars

February 02, 2015

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Gauging the CMO Biosimilar Opportunity

February 02, 2015

Market forces may limit the success of CMOs.

Particle Engineering for Bioavailability Enhancement

February 02, 2015

Enhancing Dissolution of Poorly Soluble Drugs through Jet-Milling

February 02, 2015

The authors discuss a novel particle engineering technology based on mechano-chemical activation.

In-Vivo Release Studies of Levamisole Phosphate and Ivermectin from an Isotropic Medium-Chain Mono and Diglyceride-Based Formulation Following Subcutaneous Injection in Sheep

February 02, 2015

Formulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.

Developing and Validating Assays for Small-Molecule Biomarkers

February 02, 2015

Working with biological matrices and understanding the intended use are crucial.

Special Considerations for Extractables and Leachables Testing in Biological Products

February 02, 2015

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.