The ability to link key pieces of data and mine experiments captured in BIOVIA Workbook moves a top pharmaceutical organization toward true scientific knowledge management.
Whether your relationship with the FDA starts with pre-IND feedback or simply with an IND submission itself, these early interactions will likely form the basis for a long (and hopefully happy) marriage. After all, this liaison could very well last beyond submission and initial approval of a marketing application to include additional trials relevant to the drug’s development and labeling. As there is no manual available for building an effective and collegial relationship with the FDA, this article offers helpful tips to assist sponsors in establishing and maintaining this critical union.
About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.
In June 2016, the world’s attention was captivated by a modern-day David and Goliath sports story, as the national football team from the small island of Iceland reached the quarter finals of the UEFA Euro 2016 soccer tournament.
A question and answer session with Barbara Paldus, Ph.D., Vice President and General Manager Finesse, part of Thermo Fisher Scientific
The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems. It is challenging to find optimal development solutions to enhance bioavailability for drug compounds contained within complex fill formulations . Catalent Pharma Solutions has lead research studies to establish technology can accommodate a wider range of excipients and more molecules.
An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease. However, numerous drug delivery challenges threatened the realization of the Fast Track status designation they had received due to promising early stage results. By leveraging a softgel technology, the customer was able to overcome a number of potential hurdles and expeditiously enter the Phase II/III clinical trial.
Xhale, Inc., a commercial stage medical technology company, had developed the SMART® Medication Adherence Monitoring System technology to non-invasively monitor adherence to oral medications. Efficient encapsulation of 2-butanol has to overcome many challenges, which requires optimization of not only chemical composition, but also manufacturing parameters such as lower processing temperature and thinner softgel shell.
Synthetic oligosaccharides are used in clinical practice as anticoagulants. Due to their poor oral bioavailability, oligosaccharides — along with most pharmaceutical macromolecules — are formulated as solutions or suspensions and delivered by invasive intravenous (IV) or subcutaneous injection. When oral bioavailability is increased, macromolecule can potentially be converted from injectable to oral drug delivery. This case study demonstrates how OptiGel ™ Bio technology significantly increases oral bioavailability of a synthetic oligosaccharide, thus enabling oral conversion.
This white paper explores best practices in SaaS selection and incorporation into laboratory practices that enable organizations to focus on their core competencies while utilizing best-of-breed software.
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