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To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the draft guidance “<em>Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections (Exposure Draft)</em>” (15 October 2019). This indicates that the evaluation of the consistency of injections has finally begun. This Exposure Draft clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc.
We recently sat down with Dr. Bettine Boltres, our contact for scientific affairs and technical solutions for glass. In her role she is supporting pharmaceutical companies to address glass-related topics from a scientific perspective and to gain a deeper understanding of the material that holds their valuable drug products. Having done this for many years, we wanted to know what the most frequently asked questions are that she encounters. Please read Part 1 of our two-part series around the 10 most commonly asked questions around glass vials:
In the intricate landscape of healthcare, ophthalmology stands out as a domain where innovation is not merely encouraged – it is imperative. As we delve into the realm of eye health, the question looms How can the pharma and medical device industry support patients journey? By exploring the vast unmet need in ophthalmology and focusing on developing advanced drug delivery systems, enhancing patient adherence through less invasive treatments, and improving biocompatibility and efficacy of ophthalmic devices, the industry can lead the way in this critical field and significantly ease patients’ journey.
<p><em>Teams Place 15 and 28 out of 120 Teams</em></p><p>The West DragonPhyre and DragonPhlame teams placed 15<sup>th</sup> and 28<sup>th</sup>, respectively, out of the 120 teams competing at the 11<sup>th</sup> Annual Philadelphia Dragonboat Festival on October 6, 2012.</p>
A parenteral drug product contaminated by particles is a potential health threat. In the bloodstream, particles can cause serious issues, such as capillary occlusion and immunogenic responses. In most cases, the observation of particles in a drug product leads to a recall.
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