INFUSION DRUG DELIVERY ARTICLES
The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation. What does this mean for medical device companies?
INFUSION DRUG DELIVERY RESOURCES
-
Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.
-
Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.
-
Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.
-
Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
-
Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.
-
Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.
-
Innovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.
INFUSION DRUG DELIVERY SOLUTIONS
-
These containers can be delivered with a full line of solutions used in clinical settings, including basic saline, heparin premix, and lidocaine. The chemistry used to produce the container uses neither polyvinyl chloride (PVC) nor the plasticizer DEHP.
-
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
-
B. Braun manufactures a wide variety of interventional product solutions for a multitude of medical applications and procedures. Products can be made available as stand-alone solutions or incorporated into a sterile private-labeled device or kit.
-
Examine a NVGD platform that tackles the primary obstacle hindering gene editing therapies: efficient delivery. Utilizing engineered nanoparticles, the platform overcomes limitations associated with payload size.
-
RASR filling and closing machines are designed to treat IV bags. These machines are able to fill single chamber as well as dialysis multi-chambers bags.
-
August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.
-
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
-
B. Braun OEM Division is experienced in designing and manufacturing standard and custom valves ranging from small to large scale volumes. These valve products are available as stand-alone components, or may be incorporated into sterile, private-label kits and assemblies.
-
BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.
-
By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
INFUSION DRUG DELIVERY NEWS
- Melbourne-Developed Drug Delivery Platform Delivers 'Impressive' Results In International Bowel And Ovarian Cancer Trial
- Race Executes Agreement With Ardena For GMP Manufacturing Of RC220
- Acasti Announces WuXi Clinical As CRO To Conduct STRIVE-ON Pivotal Phase 3 Safety Trial For GTX-104 In aSAH Patients
- Ascendia Pharmaceuticals Develops Novel Nanoemulsion IV Formulation For Clopidogrel That Received IND Approval
- Viridian Therapeutics Announces Partnership With Drug Delivery Innovator Enable Injections
- Scaling Up Capacity, Eitan Medical Opens New Manufacturing Facility Bolstered by Semi-Automated Production Lines