Nanomedicines and nanocarriers in clinical trials: surfing through regulatory requirements and physico-chemical critical quality attributes

Author:

Dri Diego AlejandroORCID,Rinaldi Federica,Carafa Maria,Marianecci Carlotta

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference74 articles.

1. EMA. European Medicines Agency (EMA) - Quality of medicines questions and answers: Part 1. 2022. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/qa-quality/quality-medicines-questions-answers-part-1#variation-section. Accessed 3 Apr 2022.

2. EMA. European Medicines Agency (EMA) - Guideline on process validation for finished products - information and data to be provided in regulatory submissions. 2016. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-process-validation-finished-products-information-data-be-provided-regulatory-submissions_en.pdf. Accessed 22 Apr 2022.

3. EMA. European Medicines Agency (EMA) - Quality guidelines. 2022. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/quality-guidelines. Accessed 3 Apr 2022.

4. EMA. European Medicines Agency (EMA) - Quality guidelines: specific types of products. 2022. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/quality/quality-specific-types-products. Accessed 3 Apr 2022.

5. EMA. European Medicines Agency (EMA) - Multidisciplinary quality guidelines: nanomedicines. 2022. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-nanomedicines. Accessed 3 Apr 2022.

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