| PEER-REVIEWED RESEARCH |

Optimizing Compression Coating for Pulsatile Release Tablets

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.
/ read more /

| MANUFACTURING |

Advancing Transdermal Drug Delivery

PATH’s Microarray Patch Center of Excellence aims to accelerate transdermal patch technology for public health needs.
/ read more /

| QUALITY/REGULATIONS |

QbD Takes Shape for Topical Pharmaceuticals

As they seek to increase the number of generics available, regulators are requiring that in-vitro and other test data be used for ANDAs, and promoting the concept of biowaivers that would allow such data to replace costly clinical studies.
/ read more /

Evaluating the Tech Transfer Process

Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.
/ read more /

The Cost of Brexit

Despite preparative work by the bio/pharma industry, any Brexit scenario will result in regulatory implications and increased costs.
/ read more /

| ANALYTICS |

Residual Moisture Determination in Lyophilized Drug Products

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.
/ read more /

| EDITOR'S COMMENT |

Striking a Landmark Deal

After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.
/ read more /

| EUROPEAN REGULATORY WATCH |

Investigating NDMA Impurities at EMA’s Request

Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.
/ read more /