| PEER-REVIEWED RESEARCH |

Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning Validation

In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
/ read more /

| EU REGULATORY WATCH |

The Complexity of IDMP

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
/ read more /

| DRUG DEVELOPMENT |

Transforming Regulatory Data Management

The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
/ read more /

| OUTSOURCING OUTLOOK |

CMOs and CROs Have Different Trajectories

CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.
/ read more /

| API SYNTHESIS & MANUFACTURING |

Catalysis, Flow Chemistry Impact API Manufacturing

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
/ read more /

| PACKAGING FORUM |

Robots Package Parenteral Products

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.
/ read more /

| TROUBLESHOOTING |

Optimizing Yields on Modern Tablet Presses

Learn how to prevent common causes of product loss.
/ read more /

| ASK THE EXPERT |

Engaging with Interest Groups or Industry Associations

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
/ read more /