February 2015
Volume 39, No. 2

| FOCUS |

Developing and Validating Assays for Small-Molecule Biomarkers

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

| FEATURED CONTENT |

Reinventing the Cold Chain in a High-Stakes Market

Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain. read more

Ligand-Binding Assays and the Determination of Biosimilarity

Ligand-binding assays are fundamental to characterizing biosimilars. read more

Special Considerations for Extractables and Leachables Testing in Biological Products

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

Improving Visual Inspection Practices

New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects. read more

| PEER-REVIEWED RESEARCH |

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

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

| FORMULATION |

Enhancing Dissolution of Poorly Soluble Drugs through Jet-Milling

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

| API SYNTHESIS & MANUFACTURING |

Chiral Resolution with and without Resolving Agents

Resolution technologies remain crucial for commercial-scale chiral API production. read more

| TROUBLESHOOTING |

Preventing Tablet Tooling Problems

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

| OUTSOURCING OUTLOOK |

Gauging the CMO Biosimilar Opportunity

Market forces may limit the success of CMOs. read more

| REGULATORY WATCH |

FDA Sets Policies to Enhance Drug Security and Safety

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards. read more

| OTHER FEATURES |

The New 2014 IPEC Significant Change Guide

This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version. read more

Finding Opportunities in Brazil

Changes in the country's political landscape may affect the pharmaceutical industry market in the future. read more

Cures Require Compromise

Initiatives to speed drug development must pass Congress and special interest groups. read more

| WEBCASTS |

Fundamentals of Spray-Dried Dispersion Technology

Spray-dried dispersion technology is a proven approach to improve the dissolution rate and bioavailability of low solubility compounds, and helps to bring new medicines to market. Learn the fundamentals of spray-dried dispersion formulation selection, process development, stability, scale-up, and performance considerations.

Applying Water Activity to Pharmaceutical Technology

Learn basics of water activity and the role it plays in the chemical stability, microbial content, and physical properties of pharmaceutical products. Hear experts discuss compendial and regulatory requirements for water-activity determination, and practical applications of water activity in marketed pharmaceuticals.