The Solid-State Mindset: Lessons, Surprises, and Strategies from the Front Lines of Drug Development - Softcover

Inhaltsangabe

Drugs don’t fail because their chemistry is wrong—they fail because their physical reality is misunderstood.
Most molecules entering development today are poorly soluble, structurally complex, and polymorphically rich. They behave unpredictably under stress, at scale, or in formulation—unless their solid-state landscape is understood from the start.
The Solid-State Mindset is a practical, insightful journey through the science that underpins every successful small-molecule program:

• polymorphism and crystallisation
• solubility and dissolution
• amorphous materials and particle engineering
• early formulation and preclinical vehicles
• CMC strategy and regulatory expectations
• solid-form IP, risk management, and the hidden business consequences

Drawing on years of hands-on experience in the pharmaceutical industry, Víctor M. Díaz Pérez brings together real case studies—including ritonavir, paroxetine, and gatifloxacin—along with clear explanations of the physical chemistry behind them.
This book is not a manual. It is a perspective, a way of thinking that helps scientists, founders, CMC leaders, and generic manufacturers make better decisions, earlier, with fewer surprises.
If you work with small molecules, this book will change how you see your drug.

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