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Pharma
ICH Q3E: E&L risks with Material Variability and Supply Chain
by
Gabriele Pincitore
|
31 Marzo 2026
31 Marzo 2026
|
Blog
,
Pharma
ICH Q3E places strong emphasis on understanding and controlling extractables and leachables (E&L) risks throughout...
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Permitted Daily Exposure within EMA and ICH Framework
by
Gabriele Pincitore
|
24 Febbraio 2026
26 Febbraio 2026
|
Blog
,
Pharma
Permitted Daily Exposure (PDE, also referred to as “permissible daily exposure”) is a health-based limit...
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Watching DNA Repair in Real Time: A Revolutionary New Sensor
by
Gabriele Pincitore
|
9 Dicembre 2025
9 Dicembre 2025
|
Blog
,
Pharma
Watching DNA Repair in Real Time: A Revolutionary New Sensor Our DNA is under constant...
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Trump administration to allow medications to be purchased directly from pharma companies
by
Gabriele Pincitore
|
30 Settembre 2025
30 Settembre 2025
|
Blog
,
Pharma
What is the TrumpRx platform? The Trump administration has been considering launching a government-operated website,...
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Breaking Barriers: Including Pregnant and Breastfeeding Individuals in Clinical Trials
by
Gabriele Pincitore
|
8 Luglio 2025
8 Luglio 2025
|
Blog
,
Pharma
Clinical trials have long shaped the future of medicine. But for decades, one vital population...
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Understanding the Reflection Paper on the Qualification of Non-Mutagenic Impurities: A Regulatory Perspective
by
Gabriele Pincitore
|
12 Maggio 2025
12 Maggio 2025
|
Blog
,
Pharma
Introduction In the complex world of pharmaceutical development, ensuring drug safety and efficacy is paramount....
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FDA Issues Draft Guidance on AI in Drugs and Devices
by
Gabriele Pincitore
|
18 Marzo 2025
18 Marzo 2025
|
Blog
,
Pharma
FDA Releases Draft Guidance on AI in Drug and Medical Device Development The U.S. Food...
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Machine Learning in Early Prediction of Metabolism of Drugs
by
Gabriele Pincitore
|
25 Novembre 2024
25 Novembre 2024
|
Blog
,
Pharma
Marta Lettieri, Virginia Carlucci and Marco Rodda have contributed to the latest edition of Computational...
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How Mario Draghi’s Vision for European Competitiveness Could Transform the Pharma Industry
by
Gabriele Pincitore
|
8 Ottobre 2024
8 Ottobre 2024
|
Blog
,
Pharma
The pharmaceutical industry stands at the crossroads of significant transformation as Europe rethinks its global...
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New ERA Guideline released on March 2024 by EMA. What changes in the Environmental Risk Assessment of medicines (ERA)?
by
Gabriele Pincitore
|
21 Maggio 2024
21 Maggio 2024
|
Blog
,
Pharma
What is the environmental impact assessment of active pharmaceutical ingredients? Environmental impact assessment of active...
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