About this ebook
AI for Pharmaceutical Development bridges that gap. This practical, vendor-neutral guide maps AI capabilities to the post-discovery lifecycle, from formulation and quality by design through clinical development, regulatory science, and pharmacovigilance. It offers step-by-step workflows, decision matrices, and compliance checkpoints that pharmaceutical professionals can apply immediately.
The book is built on a core premise: AI is a powerful decision-support tool, not a replacement for scientific judgment or GMP compliance. Every chapter enforces this boundary with explicit validation requirements, human oversight protocols, and risk-based use case distinctions.
• Maps six stages of pharmaceutical development and shows exactly where AI can add value.
• Establishes data readiness, integrity, confidentiality, and organizational governance before domain applications.
• Demonstrates AI-assisted workflows for formulation strategy, excipient selection, QbD/DoE, stability, PAT, deviation investigation, clinical trial monitoring, regulatory writing, and pharmacovigilance.
This book was written for practicing scientists and engineers in regulated environments. Formulation scientists, manufacturing engineers, QA/QC specialists, clinical development professionals, regulatory affairs officers, and pharmacovigilance experts will find actionable guidance grounded in real-world tasks and regulatory expectations.
If your organization is exploring AI in pharmaceutical development, this is the resource to ensure you move forward with clarity, confidence, and full compliance.
