Dosage Forms

Reshaping Dosage Forms

Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Frontrunners in Bispecific Antibodies

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Amgen Announces Humira Biosimilar Clinical Studies Success

February 06, 2015

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.

First Inhalable Insulin Comes to the US

February 04, 2015

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

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.

Preventing Tablet Tooling Problems

February 02, 2015

Tooling can be damaged by poor handling or problems in process design or material choice.

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.

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.