The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug ...
8 PSGs for complex products (5 new and 3 revised PSGs), several of which include in vitro bioequivalence (BE) options for assisting generic drug development. Notable new guidances for complex products include: Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifena...
ProductIPedia Get guidance towards starting with the ProductIP platform. Learn more about Product Compliance. Do not know what certificates you need? Did someone asked you for documents? ProductIPedia is here to help. Start learning Services Each company is different but they all share the same ...
由欧洲药品管理局(EMA)发布的关于Asenapine product-specific bioequivalence guidance(阿塞那平-生物等效性),来源于药智数据政策法规数据库。
Cognito, Lambda, and AWS Identity and Access Management (IAM) are services deployed in this Guidance to enhance your security. IAM can be used to create fine-grained roles and policies to control who can manage and create your APIs, as well as control who can invoke them. To control acce...
experience and satisfaction. When customers reach out with questions or concerns, they expect quick, accurate, and helpful solutions. Well-trained support team members can turn frustrated customers into loyal brand advocates by providing expert guidance, resolving issues efficiently, and communicating with...
Lenovo EasyResume — Gives quick recovery from computer lid close, balancing low power state by suppressing CPU usage at lid closeRack Planner — Helps users better plan for rack efficiency by increasing rack density and calculating power consumption based on specific configurations ...
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That you are able to search for specific part numbers by entering them into the search field on our website satair.com 8 | Global Product Capability Did you know? That even if you might not find the product or manufacturer you are searching for here, we still might be able to help you...