PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs. / read more /
Employing a Lean Lab Approach to Optimize Lab Processes: Part 1: Work Smarter Not Harder LIVE WEBCAST: Tuesday April 26, 2016 at 7 am PDT | 10 am EDT | 2 pm GMT | 3 pm BST | 4 pm CET When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel. Free registration
The National Institute of Health will conduct an internal review of the National Cancer Institute's cell manufacturing facilities, which will affect multiple Kite projects. / read more /
Plasticell was recognized for its contribution to the advancement of regenerative medicine, cell and gene therapy, as well as other areas of biomedical research. / read more /
Ensuring Effective Drug Stability Studies Drug Stability Testing from Development to Shipping
LIVE WEBCAST: EU: Wednesday, April 27, 2016 at 11 am CEST In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation. Free registration
Industry experts and FDA’s Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms. / read more /
Proper drug release of high-dose hydrophilic drugs is a challenge for formulators since both the initial drug burst release, as well as the consequent sustained release, need to be controlled. Excipients can provide an answer to drug release challenges when their hydrophobic nature is coupled with thermal sintering. This approach intensifies the retardation of drug release by forming plastic matrices of high mechanical strength, which can withstand dose dumping and achieve controlled release. In this webcast, a formulation expert will discuss BASF's Kolliwax grades and their suitability for thermal sintering; describe how high-dose hydrophilic actives were selected to demonstrate the efficacy of thermal sintering (60-65% w/w) using Kolliwax grades; and present processing parameters to enable customers to reproduce controlled drug release of hydrophilic drugs using thermal sintering. Sponsored by BASF
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines. Sponsored by Patheon
A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products. / Click here /
New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.
