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Computed tomography for in-depth investigation of freeze-dried products

European Pharmaceutical Review

1 In addition, the CT images reveal the distribution of the active ingredients and help to account for fracture behaviour. 4 The freezing rate influences the pore size and distribution, which is then detected in the 3D image, allowing the process parameters to be optimally adapted to the desired properties of the end product.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103
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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.” New general obligations on SoHO entities and SoHO establishments The proposal introduces new general obligations on SoHO entities and SoHO establishments.

Safety 75