"Navigating FDA Drug Approval: A Comprehensive Guide to Application Success" is an essential resource for pharmaceutical professionals, researchers, and innovators seeking to bring their drug products to market. This book demystifies the complex FDA approval process, providing step-by-step guidance on everything from preclinical trials to New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Biologics License Applications (BLA). Packed with insights into expedited approval pathways, labeling requirements, post-marketing surveillance, and key FDA interactions, this guide equips readers with the knowledge and strategies needed to avoid common pitfalls and achieve regulatory success. Whether you're a seasoned developer or new to the field, this comprehensive guide will help you navigate the regulatory landscape with confidence.

Before approving a drug, the FDA assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint (SE) -- a laboratory measure, such as blood pressure -- instead of more direct clinical evidence, like preventing strokes. After approval, FDA requires a drug sponsor to further study the drug. There have been concerns about FDA's reliance on SE and its oversight of post-marketing studies (PS). This report provides info. on: (1) all drug applications approved based on SE in FDA's accelerated approval process; (2) a subset of applications for potentially innovative drugs approved based on SE under FDA's traditional process; and (3) FDA's oversight of PS. Illustrations.

Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade's numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. - Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues - Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included - Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics - All chapters are written by experts with a wide range of practical experience from the industry and academia

This volume of the IARC Monographs provides an assessment of the carcinogenicity of 14 drugs and herbal products. The IARC Monographs Working Group relied mainly on epidemiological studies to evaluate the carcinogenic hazard to humans exposed to the drugs digoxin (widely prescribed for the treatment of chronic heart failure), pioglitazone (used for the treatment of type 2 diabetes mellitus), and hydrochlorothiazide (used to treat hypertension). Other agents evaluated included the drugs primidone, sulfasalazine, pentosan polysulfate sodium, and triamterene, and five herbal products (or their components): Aloe vera whole leaf extract, goldenseal root powder, Ginkgo biloba leaf extract, kava extract, and pulegone. In view of the limited agent-specific information available from epidemiological studies, assessments of these agents relied mainly on carcinogenicity bioassays to reach conclusions as to the carcinogenic hazard to exposed humans.