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  • Format: ePub

Pharma Sprint 30 - ICH Skill Burst is a practical guide designed for pharma professionals and students, focusing on the International Council for Harmonisation (ICH) guidelines essential for drug quality, safety, and efficacy. Covering 30 essential skills, the book provides actionable insights into quality, safety, efficacy, and multidisciplinary aspects (Q, S, E, M), integrating QbD, GMP, analytical validation, and pharmacovigilance. Real-world case studies and examples help readers apply guidelines effectively in formulation, clinical trials, regulatory submissions, and audits. Ideal for…mehr

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Produktbeschreibung
Pharma Sprint 30 - ICH Skill Burst is a practical guide designed for pharma professionals and students, focusing on the International Council for Harmonisation (ICH) guidelines essential for drug quality, safety, and efficacy. Covering 30 essential skills, the book provides actionable insights into quality, safety, efficacy, and multidisciplinary aspects (Q, S, E, M), integrating QbD, GMP, analytical validation, and pharmacovigilance. Real-world case studies and examples help readers apply guidelines effectively in formulation, clinical trials, regulatory submissions, and audits. Ideal for QA/QC professionals, formulation scientists, regulatory specialists, and clinical researchers, this guide empowers readers to enhance professional competence, ensure compliance, optimize processes, and improve patient safety.


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