Häftad, Engelska, 2026

Biophysical Foundations of Quality by Design and Analytical Validation in Pharmaceuticals

Av Muhammad Sajid Hamid Akash, Kanwal Rehman

2899 kr

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Beskrivning

Biophysical Foundations of Quality by Design and Analytical Validation in Pharmaceuticals addresses a critical need for integrating molecular-level biophysical understanding into pharmaceutical development and quality assurance. This reference explores how biophysical principles influence drug stability, folding, aggregation, and intermolecular interactions, which are essential for ensuring product quality and consistency. It provides detailed insights into the regulatory landscape, emphasizing lifecycle management, control strategies, and molecular characterization techniques. The book’s detailed table of contents encompasses chapters on regulatory workflows, design space development, analytical lifecycle management, biophysical characterization methods, computational modeling, and applications in biopharmaceuticals. It offers practical guidance through case studies, highlighting how scientific tools support risk assessment, process optimization, and regulatory compliance across drug modalities, including biologics and advanced delivery systems.

Integrates biophysical principles with QbD and analytical validation frameworks
Demonstrates lifecycle management strategies for pharmaceutical quality
Provides practical case studies on biophysical characterization techniques
Connects regulatory expectations with scientific, data-driven approaches
Supports development of robust, compliant pharmaceutical products

Produktinformation

Utgivningsdatum: 2026-12-15
Mått: 191 x 235 x undefined mm
Format: Häftad
Språk: Engelska
Antal sidor: 470
Förlag: Elsevier Science
ISBN: 9780443494192

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Mer information

Dr. Akash is currently working as an Associate Professor at the Department of Pharmaceutical Chemistry, Government College University Faisalabad, Pakistan. He got his PhD degree in Pharmaceutical Analysis from Zhejiang University, China. Currently, he is focusing on investigating the effect of endocrine disruptingchemicals on various molecular and metabolic pathways that are involved in metabolic disorders and their treatment strategies. His research work is cutting-edge and worthy of extension in developing countries, like Pakistan, where it can be most beneficial and cost-effective, especially for diabetic patients. Based on his significant scientific contributions inthe field of Pharmaceutical Sciences, he has been awarded “Research Productivity Awards from the Pakistan Council for Science and Technology, the PAS Gold Medal from the Pakistan Academy of Sciences, and the A.R. Shakoori Gold Medal from the Zoological Society of Pakistan. Dr. Kanwal Rehman is working as an Associate Professor at the Department of Pharmacy in The Women University, Multan, Pakistan. Dr. Rehman received her PhD in Pharmacology from Zhejiang University, China. She nurturesa keen interest in the pathogenesis of metabolic disorders and new therapeutic modalities for its treatment. Currently, sheis focusing on the investigation of the role of pharmacogenomics based upon gene polymorphism on various molecular andmetabolic pathways that are involved in mitogenic disorders and treatment strategies, like natural biogenic compounds against different risk factors of metabolic disorders, including pancreatitis, cardiometabolic disorders, and hormonal imbalance. Dr. Rehman has also been awarded the Research Productivity Award by the Pakistan Council for Science and Technology, Pakistan; the PAS Gold Medal from the Pakistan Academy of Sciences; and the A.R. Shakoori Gold Medal from the Zoological Society of Pakistan.

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