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Note: West’s SmartDose® drug delivery platform is not independently cleared or approved by any Regulatory Body for general healthcare professional or patient use, nor is it available for general commercial purchase. Its distribution and use are subject to applicable regulatory requirements for clinical investigation, and for marketing authorization, as used in combination with a specific drug or biological product. Each constituent part of a combination product is subject to the requirements established by the Regulatory Body for that type of constituent part (drug, biologic or device) and when evaluating products that utilize a specific drug delivery system or device the Regulatory Body is expected to evaluate the characteristics of that delivery system and its functionality, as well as the potential for undesirable interactions between the drug or biologic and the delivery system. The regulatory process can be more complicated for combination products. As a result, we note that the SmartDose® drug delivery platform’s compatibility with any particular drug or biologic must be confirmed, and its ability to achieve the desired patient benefits must also be confirmed, on a case-by-case basis in a manner sufficient to meet Regulatory Body requirements.
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Flurotec® is a registered trademark of Daikyo Seiko, Ltd.
SelfDose™ is a trademark of West Pharmaceutical Services, Inc.
The logos above are the property of their respective owners and are used with permission.
Imagine self-administered cancer treatments in the comfort of a patient’s home. How close are we to making this a reality? During this unprecedented time, immuno-compromised patients can benefit from receiving a self-administered, home-based treatment option. One major factor into making home-based cancer treatment a reality is a focus on shifting the route of administration from intravenous to subcutaneous delivery. Due to an emphasis on patient involvement in shared decision making for health care policy and medical approaches, understanding the intravenous to subcutaneous transition in medical injections has garnered increased importance. If therapeutic efficacy is not compromised, the less invasive nature and convenience of subcutaneous injections is often the preferred route of administration.1-2,4-6
The impact of a cancer diagnosis can be stressful. Questions such as “how will I tell my family?”, “how will I afford to pay my bills?”, “will I ever work again?” and even “will I survive?” are at the forefront of the patient’s mind as they process their diagnosis and begin treatment. So, how can the patient experience with treatment be supported? By offering the best quality of care.
In the biologics space, there are clear trends toward higher delivery volumes, less frequent dosing, and the conversion from intravenous to subcutaneous delivery. This is driving demand for wearable technologies. Read more below about the FDA’s Patient-Focused Drug Development (PFDD) Initiative and how these findings can enable more insightful patient offerings.
Imagine self-administered cancer treatments in the comfort of a patient’s home. How close are we to making this a reality? During this unprecedented time, immuno-compromised patients can benefit from receiving a self-administered, home-based treatment option. One major factor into making home-based cancer treatment a reality is a focus on shifting the route of administration from intravenous to subcutaneous delivery. Due to an emphasis on patient involvement in shared decision making for health care policy and medical approaches, understanding the intravenous to subcutaneous transition in medical injections has garnered increased importance. If therapeutic efficacy is not compromised, the less invasive nature and convenience of subcutaneous injections is often the preferred route of administration.1-2,4-6
The impact of a cancer diagnosis can be stressful. Questions such as “how will I tell my family?”, “how will I afford to pay my bills?”, “will I ever work again?” and even “will I survive?” are at the forefront of the patient’s mind as they process their diagnosis and begin treatment. So, how can the patient experience with treatment be supported? By offering the best quality of care.
In the biologics space, there are clear trends toward higher delivery volumes, less frequent dosing, and the conversion from intravenous to subcutaneous delivery. This is driving demand for wearable technologies. Read more below about the FDA’s Patient-Focused Drug Development (PFDD) Initiative and how these findings can enable more insightful patient offerings.
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