Book excerpt: Molecular Pharmaceutics and Nano Drug Delivery: Fundamentals and Challenges provides a thorough resource for both beginners and established scientists, bringing fundamental knowledge about key challenges of these carriers down to the molecular level. The book satisfies the need of availability of literature at single platform with the detailed knowledge to understand crucial aspects, such as regulatory, clinical, toxicological and the formulation requirements of these carriers. This is a valuable resource for graduates, pharmaceutical researchers and anyone working on aspects of pharmaceutics, molecular pharmaceutics and nano-drug/gene delivery. So called ‘novel drug delivery systems’ are numerous, with each having different approaches to their production, characterization and evaluation. The proper understanding of these dosage forms, as well as their critical attributes such as toxicity and regulatory requirements are aspects which researchers should know before they begin working on these carriers. This book provides this critical information. Provides a conceptual understanding of Molecular Pharmaceutics and drug/gene delivery systems of biological origin Presents a detailed description and discussion on nanotechnological carriers, from basics to advances, including gene delivery and protein-oriented delivery Includes regulatory and toxicological requirements for novel drug delivery systems