Biosimilars. Design and analysis of follow-on biologics (Q2852237)

This book is a comprehensive treatise on small molecule drug products and biological products. It covers a great deal of controversies regarding bioequivalence between the two types of drugs. The laws regarding biosimilarities and bioequivalence followed by some prominent countries are quoted. Another facet is the coverage of statistical methods and designs used to measure the equivalence between two types of drugs. Statistically one would compare similarity with regard to average and variability. The methods also deal with study endpoints in terms of drug absorption. Once the data are collected on the effect of biological and generic medicines, they are analyzed as design and sampling procedures. Parametric and nonparametric tests are used for testing of hypotheses with regard to quality, efficacy and stability of two types of drugs. These hypotheses are either in terms of average effect or the variability amond the drug effects. Besides tests, confidence interval approaches have been exorbitantly applied. The author has referred hundreds of studies conducted all over the word. On the whole, this book is highly informative, technically sound and scientifically up-to-date. One would be benefitted very much by studying this book in the area of medical sciences.