BD
About BD
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US
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2017On CPHI since
Products from BD (3)
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Product BD Vystra™ Disposable Pen
Discover our portfolio of solutions and services for a wide variety of therapeutic areas and settings: from home to hospital through outpatient clinic, and from vaccines to chronic disease treatments through small molecules and specialties, dermal fillers and contrast media… We provide unparalleled parente... -
Product BD Physioject™ Disposable Autoinjector
Discover our portfolio of solutions and services for a wide variety of therapeutic areas and settings: from home to hospital through outpatient clinic, and from vaccines to chronic disease treatments through small molecules and specialties, dermal fillers and contrast media… We provide unparalleled parente... -
Product BD Intevia™ Disposable Autoinjector
Discover our portfolio of solutions and services for a wide variety of therapeutic areas and settings: from home to hospital through outpatient clinic, and from vaccines to chronic disease treatments through small molecules and specialties, dermal fillers and contrast media… We provide unparalleled parente...
BD Resources (3)
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News Pharmapack 2024 - From the Floor
Paris once again welcomes Europe’s leading trade show in pharmaceutical packaging and drug delivery innovation. Join our content team as Pharmapack 2024 opens its doors to leading experts and innovators in pharmaceutical packaging and drug delivery. -
Brochure BD Product Portfolio
Discover our portfolio of solutions and services for a wide variety of therapeutic areas and settings: from home to hospital through outpatient clinic, and from vaccines to chronic disease treatments through small molecules and specialties, dermal fillers and contrast media… We provide unparalleled parenteral drug delivery systems, including glass and plastic syringe systems, self-injection devices, safety and shielding systems that set the standard. -
Video De-risking Drug-Device ANDA Submissions: A Case Study Using Comparative Analysis and Human Factors Data
When submitting a generic drug-device combination product in the US, pharmaceutical companies must follow the FDA guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry”. As part of this guidance, a threshold analysis is performed to assess the differences between the Reference Listed Drug (RLD) and the generic drug. If “other” differences are identified, a comparative use human factors (CUHF) study may be needed to prove the non-inferiority between the two products. During this presentation, a case study will show how a device constituent developer performed a comparative analysis and formative CUHF study to help inform pharmaceutical companies’ final CUHF parameters and de-risk their combination product ANDA submission.
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