Drug Development

Articles

Research by agency scientists may help speed development of Zika virus vaccines.

FDA Researchers Develop Mouse Model for Zika Studies

Agnes Shanley is senior editor of Pharmaceutical Technology.

Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.

Ensuring Quality in Pharmaceutical Raw Materials

Idifarma has announced a growth of more than 50% over the past two years. Revenue is expected to hit approximately EUR5.3 million in 2016, growing from EUR3.5 million in 2014.

Idifarma Reports Record Growth

The study in 48 healthy adults will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of the RSV vaccine, SynGem.

Mucosis Starts Phase I Trial of Needle-Free Nasal-Spray RSV Vaccine

The new facility will focus on formulation development, drug product analytical development, and quality control.

Lonza Holds Grand Opening of New Drug Product Services Labs

German biotech ARTES and Iranian biopharma manufacturer BioSun will develop an HPV vaccine.

ARTES and BioSun Collaborate on HPV Vaccine

David W. Osborne, PhD, is Chief Scientific Officer and Founder, Independent Derm Solutions, LLC, 4215 Creekside Court, Fort Collins, CO 80525.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Reliable, high-quality products require innovative analytics and production.

Biosimilars to Drive Modern Manufacturing Approaches

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

Dissolution Testing

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.

Formulation and Drug Delivery