Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields.

Nanotherapeutics in Cancer Vaccination and Challenges consolidates the current research on cancer nanomedicine and therapeutic cancer vaccination to explore the most effective and promising avenues. The book covers cancer vaccines before exploring nanotherapeutics, DNA and mRNA vaccines in cancer treatment. Finally, it considers regulatory and industrial perspectives on cancer vaccination and nanotherapeutics. This resource will be useful for pharmaceutical scientists and researchers focused on biomedical engineering, chemical engineering, vaccine development, and cancer immunotherapy, along with advanced students in these subjects. Cancer is arguably the most complex and challenging disease known to mankind. Over the last two-decades, significant advancements have been made in new and novel concepts of cancer nanomedicines. Therapeutic cancer vaccines may be utilized to inhibit further growth of advanced cancers and/or relapsed tumors that are refractory to conventional therapies, such as surgery, radiation therapy and chemotherapy.

The nanotheranostics sector provides a very promising strategy for monitoring drug biodistribution and pathology longitudinal processes by integrating the imaging and drug delivery functions in one single nanoformulation, providing vital insights into the identification of tumour and predicting the efficacy of nanomedicine. For its unique properties, which include their small size and biocompatibility and ability to permeate the cellular membrane with carrying drugs, nanomaterials have been used for various biomedical applications. This book covers the progress made in hormone-related cancer and their management by nonmedicinal therapy for targeting the hormone regulated cancer with their clinical progress and clinical hurdles.