546 pages | 12 Color Illus. | 68 B/W Illus.
Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development.
Entirely focused on preformulation principles, this fully revised and updated Handbook of Preforumulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.
First Edition. Drug Discovery Trends. Intellectual Property Considerations. The Scope of Preformulation Studies. Dissociation,Partitioning and Solubility. Release, Dissolution and Permeation. Solid State Properties. Dosage Form Consideration in Preformulation. Chemical Drug Substance Characterization. Characterization of Biopharmaceutical Drugs. Characterization of Phytomedicines. Second Edition. Regulatory Aspects. The three classes of drugs and current regulatory guidance. Drug development stages, historical perspective and futuristic expectations. Market Demands for NCEs—trends. Scope and Stages of Preformulation Studies. Freedom to Operate Focus. From Methodologies to Chemical Identity. Advances in Analytical Methodologies. Physicochemical Properties. Dissociation, Partitioning and Solubility. Release, Dissolution and Permeation. Prodrug Considerations. Solid State Properties. Dosage Form Consideration in Preformulation. Chemical Drug Substance Characterization. Characterization of Biopharmaceutical Drugs. Characterization of Phytomedicines. Research and Development Team Building. Regulatory Expectations of Major Agencies. Fast to Market Approach. Bibliography (includes research publications and patent references).