Quality by Design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The emphasis of QbD began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.
To allay fears about manufacturing changes, valuable tools are now in places by the FDA to facilitate these transitions. By not understanding the availability and value of these resources, manufacturers are making a sizeable mistake that could potentially impede the industry’s passage into the next phase of modernized manufacturing.
As pharma R&D groups attempt to control the firehose of molecules coming down the pipeline, there is an increased need for more flexibility and efficiency in process development, specifically when it comes to the management and accessibility of data. In a scenario where processes move to a continuous flow, analyzers are producing data simultaneously that must be processed at the same time, making the existence of cloud-based tools for data management crucial.
While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. To address this issue without preventing legitimate patients from receiving their necessary medication, Grünenthal set out to create an abuse-deterrent formulation with a technology that creates a physico-chemical barrier to abuse and, as a result, safeguards patients from the battle of addiction.
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.
Biopharma firms function in a risky development environment with compressed timelines and budget constraints. Companies often overlook critical factors that could delay or suspend efforts down the road. Consultants should help clients understand five key risks in order to avoid costly problems and maximize financial returns during the development process.
A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.
Packaging and presentation is crucial to study success. Drug stability, regulatory strategy, and patient-centered design are just some of the factors to consider. Explore the best packaging strategies to achieve longer stability and adherence.
Pharmaceutical companies face a number of challenges when sourcing comparator compounds for clinical trials, including addressing product lead times, availability, expiry limitations, safety or cost. Learn how clinical trial sponsors can determine the best strategy to meet these challenges.
An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. Forecasting and demand simulations are useful for anticipating when and where stock is likely to be needed to formulate a kit production and distribution strategy.
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