Schlagwörter » + Ich

International Council of Harmonization Q7-Q14

The Pharmaceutical GMP Professional certification from the ASQ body of knowledge has, as its first area, Regulatory Agency governance, as it should, as a solid understanding of not only what the regulations and guidances say is important, it is pretty important to understand the why, and how they work together. 1.296 weitere Wörter

Quality Intelligence

Visualizing STF Content in a Browser Using the ICH Stylesheet

Currently we are receiving many support questions regarding an issue that arises when displaying STF study reports in a browser using the new stylesheet version 2-3. 177 weitere Wörter

Industry-specific Topics

ICH Q12: Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

ICH Q12: Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, 1-2

Recent ICH quality guidelines (Q8–Q11)(3−6) have focused on providing guidance on the development and manufacture of drug substances (Q11) 1.095 weitere Wörter

Da bin ich

Morgens wache ich auf und bin da.

Bin genauso da, wie ich auch ins Leben gekommen bin.

Bin einfach da.

Habe nicht entschieden hier zu sein, habe aber auch nichts dagegen. 235 weitere Wörter

You And I

New ICH Guidelines: ICH Q13 on Conti Manufacturing and ICH Q14 on AQbD

New ICH Guidelines:

*ICH Q13* on Continuous Manufacturing &
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*ICH Q14* on ATP – QbD (Analytical target profile and quality by design)
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New ICH Guidelines: ICH Q13 on Conti Manufacturing and ICH Q14 on AQbD… 275 weitere Wörter

How does serum potassium affect stroke risk and outcome?

Serum potassium is positively associated with stroke and mortality in the large, population-based malmö preventive project cohort.

Johnson LS, Mattsson N, Sajadieh A, Wollmer P, Söderholm M… 284 weitere Wörter

Stroke

International Trends in Drug Registration and Evaluation [Part 2: eCTD v4.0]

Our last blog post on this topic covered eCTD v3.2.2 and its advantages over paper or non-eCTD electronic submissions. The main selling points of v3.2.2 are its reliable presentation of information to reviewers, the level of flexibility for national authorities, the metadata for automated processing, the life cycle information on documents, and the reuse of information. 629 weitere Wörter

Industry-specific Topics