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 Trife...
To streamline the drug approval process, the Division of Bioequivalence posts the Bioequivalence Recommendations for Specific Products guidances on the FDA ... P Kaur,CS Chaurasia,BM Davit,... - 《Journal of Clinical Pharmacology》 被引量: 9发表: 2013年 Pharmaceutical impurities: Regulatory perspect...
1.1.Atlassian Intelligence and Rovo. Atlassian makes Atlassian Intelligence and Rovo available to customers as described in these Product-Specific Terms (together, the “AI Offerings”). 1.2.Loom AI. Loom AI is not covered by these Product-Specific Terms. It is covered separately,here. ...
Publication of Guidances for Industry Describing Product-Specific Bioequivalence RecommendationsJeffrey Shuren
1.1.Atlassian Intelligence and Rovo. Atlassian makes Atlassian Intelligence and Rovo available to customers as described in these Product-Specific Terms (together, the “AI Offerings”). 1.2.Loom AI. Loom AI is not covered by these Product-Specific Terms. It is covered separately,here. ...
Instead of just asking people whether they like it or not, ask specific questions like, “Based on the design, what kind of product do you think is in this box?” and “If you saw this in your mailbox, would it make you smile?” The more information you can get, the better. ...
Guidance for industry-product quality review 产品质量回顾指南 Guidance for Industry: Product Quality Review Version 1.0 Drug Office Department of Health
While product managers (PMs) draw on the product strategy to create the product roadmap, the whole product team should use the strategy to guide day-to-day decisions onbacklog management,feature prioritization, and paying downtechnical debt. The product strategy also offers guidance to other busin...
In most areas the guidance applies to both producers and distributors, but where requirements are different the following definitions of producer and distributor should help readers decide what action is relevant to them. The Regulations define a producer as: ...
AR is also gaining the attention in OP applications, where its task is to convert logical information into visual guidance for an order-picker [34]. The order-picker must wear specialized glasses, which leaves both hands free for order-picking. Despite its time efficiency picking accuracy and ...