Mar 15, 2016
Sponsored Content
Data integrity is a fundamental component in a quality pharmaceutical system, ensuring that medicines are safe and effective. To satisfy the changes to MHRA/FDA regulatory requirements, pharmaceutical companies must continuously improve to create a Culture of Quality. Download our white paper on how to implement a Culture of Quality for Data Integrity in a Business.
Mar 07, 2016
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Two-piece hard shell capsules made from hydroxypropyl methylcellulose (HPMC) are emerging as an alternative to conventional gelatin capsules for oral drug delivery when there is a physical incompatibility with gelatin. A new HPMC-polymer capsule without secondary gelling agents developed through a thermo-gelation process (Vcaps Plus) has shown dissolution profiles similar to hard gelatin capsules, including pH and ionic independence. Although HPMC capsules are used in marketed drugs, there are few comparisons of the in vivo performance between gelatin and HPMC in literature. In this executive summary, experts will present the in vitro dissolution and an in vivo bioequivalence study comparing the performance of the identical formulation of three different drugs in Vcaps Plus capsules to hard gelatin capsules. In addition, the circumstances under which the same API and formulation contained in HGC and Vcaps Plus can be expected to provide equivalent performance will be discussed.
Mar 02, 2016
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In this note we compared the performance of Agilent Poroshell HPH C18 columns and columns from another vendor for the analysis of tricyclic antidepressants.
Feb 26, 2016
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As more drug companies adopt comparative effectiveness studies, drug supply professionals are challenged with sourcing and managing comparator drugs. This ebook examines research from the Tufts Center for the Study of Drug Development, and reviews the pros and cons of the transactional and strategic comparator sourcing models to aid in the development of effective sourcing approaches. Special considerations, and commonly encountered issues in biologics sourcing are discussed. In addition, areas to consider in equivalence testing for comparability are reviewed.
Feb 26, 2016
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The introduction of UHPLC revolutionized bio/pharma analytical laboratories and advances in technology promise more for the future. In this ebook, experts explain recent advances in UHPLC, and the basics of glycan analysis. Sample preparation technologies that can increase sample throughput and improve data quality for peptide quantitation are explored. In addition, the characterization of intact antibodies using reversed-phase chromatography is detailed.
Review UHPLC workflows for:
• Glycan analysis
• Peptides
• Monoclonal antibodies
Feb 20, 2016
Sponsored Content
Rottendorf Pharma was selected as the contract manufacturer because of its ability to adapt from lab-scale equipment to larger batch sizes, while optimizing the process not just for clinical trial batches, but with commercial distribution in mind.
Feb 20, 2016
Sponsored Content
All drug products go through the transfer and validation process to ensure optimal manufacturing processes are established for cost-effective, timely production – whether for established product on the market or newly approved drugs.
Feb 11, 2016
Sponsored Content
Almost every organic material is combustible. Find out how VAC-U-MAX’s “Intrinsically-Safe” compressed air-powered industrial vacuums meeting NFPA 70 requirements for grounding & bonding, prevent dust exposure, and promote safer plant environments. Download whitepaper.
Feb 10, 2016
Sponsored Content
Lipids consisting of medium chain fatty acids are commonly used in the development of lipid-based selfemulsifying and self-microemulsifying drug delivery systems. However, no systematic approach to selecting one lipid over another has been reported in the literature.
Feb 05, 2016
Sponsored Content
Learn about the basics of the ICH Q10 model, the four pillars of ICH Q10 and how to apply them and how the Quality Management System ensures ICH Q10 compliance.
