This book describes concepts, principles, methodology and applications of research methodologies and biostatistics as per the syllabus prescribed by various Universities and Pharmacy Council of India (PCI) for the subject entitled ? Research Methodologies and Biostatistics? of B.Pharm., M.Pharm and Ph.D programmes. Biostatistics is a relatively new but rapidly expanding field of science, which find wide applications in pharmacy and pharmaceutical research. Pharmacy is a research based discipline. A knowledge of basic concepts of research, research methodologies, experimental designs and protocols and analysis of data resulting in good and meaningful interpretation are vital requirements for successful research in pharmacy. This book has been designed to make the subject more interesting, more comprehensive and easy to grasp. The subject is presented in a modulated and graded manner, beginning with basic concepts and then gradually from the simple to advanced topics, making the students progress smooth, easy and pleasant. The uniqueness of the textbook is to include a number of solved problems and case studies at the end of each topic. Special emphasis is given on topics like experimental designs and protocols for human and animal studies, design of experiments (DOE), tests of significance including non - parametric tests, analysis of variance (ANOVA), optimization techniques, factorial experiments and optimization by factorial designs, correlation and regression, probit analysis and determination of LD50 and ED50. A chapter on patentable research in pharmacy, patenting procedures with examples is also included.