The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides. The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.

The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides.   The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape.   The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.

With ever-rising ground, water and atmospheric pollution, every other day one hears the name of a new disease. In fact, ever since man began drifting away from Nature, he has been falling into the trap of a materialistic lifestyle that has desensitised him. Today, we breathe air thick with exhaust fumes, eat processed junk food that has no nutritive value, drink toxic carbonated beverages and lead sedentary lives. In fact, all of these have contributed to different kinds of problems for us at regular intervals. This book shows you how to go back to Mother Nature to beat even the most troublesome and chronic ailments. With natural preventive measures that emphasise Diet and Nutrition, exercise and herbal remedies, there are no fear of side- effects. This book shows you a safe, natural and enjoyable means to overcome it. Most of the ingredients mentioned in the book are the kind available in home gardens or off the kitchen shelf. The book also includes hints for different stages in life. A separate section deals with varied problems in - a woman's life through adolescence, pregnancy, lactation, menopause and general ailments. Once you have read this book from cover to cover, you need not rush to the doctor every now and then, but will be able to take care of your own and your family's health yourself.