FORMULATION

Demonstrating Therapeutic Equivalence for Generic Topical Products

The determination of topical bioequivalence requires a multi-faceted approach, tailored specifically to the generic-drug formulation.
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SUPPLY CHAIN

Piloting Track-and-Trace Implementation

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
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PEER-REVIEW RESEARCH

Identifying Causes Of Delamination

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.
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REGULATORY WATCH

EU's New Telematics Strategy for the Regulation of Medicines

The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.
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DRUG DEVELOPMENT

Risk-Sharing Agreements in the EU and Considerations for Moving Forward

The authors look at key factors driving the risk-sharing agreements that have been implemented to reduce drug expenditures across Europe.
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OUTSOURCING REVIEW

CMOs Continue to Improve Overall Biomanufacturing Performance

Better process development is creating industry benchmarks for bioprocessing.
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API SYNTHESIS & MANUFACTURING

Advances in Heterocyclic Chemistry for API Synthesis

Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C-H silylation reactions.
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TROUBLESHOOTING

Using Dynamic Thermal Imaging to Correct Sealing Problems

Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.
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Webcasts

Sample Preparation Technologies for Improved Peptide Quantitation Workflow

Sponsored by Thermo Fisher Scientific
Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.

Capsule Filling: Manufacturing Efficiency and the Added Value of Technical Service

Sponsored by Capsugel
As challenging new formulations are developed, how prepared is your team to optimize the formulation performance in encapsulation? This webinar will provide insight into improving productivity in the use of capsules for pharmaceutical products for both the formulator and supply chain. Capsule filling technologies, dosing options, excipients, capsule selection, and other factors will be discussed. An example from the field will illustrate encapsulation practices.