Sarwar Beg - Böcker

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials.

Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process.

Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Chitosan in Drug Delivery provides thorough insights into chitosan chemistry, collection, chemical modifications, characterization and applications in the pharmaceutical industry and healthcare fields. The book explores molecular weight, degree of deacetylation and molecular geometry, emphasizing recent advances in the field as written by academic, industry and regulatory scientists. It will be a useful resource for pharmaceutical scientists, including industrial pharmacists, analytical scientists, postgraduate students, health care professionals and regulatory scientists actively involved in pharmaceutical product and process development in natural polymers containing drug delivery.

Provides methodologies for the design, development and selection of chitosan in drug delivery for particular therapeutic applications Includes illustrations demonstrating the mechanism of biological interaction of chitosan Discusses the regulatory aspects and demonstrates the clinical efficacy of chitosan

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.

Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

Chitosan in Biomedical Applications provides a thorough insight into the complete chitosan chemistry, collection, chemical modifications, characterization and applications of chitosan in biomedical applications and healthcare fields. Chitosan, a biopolymer of natural origin, has been explored for its variety of applications in biomedical research, medical diagnostic aids and material science. It is the second most abundant natural biopolymer after cellulose, and considered as an excellent excipient because of its non-toxic, stable, biodegradable properties. Several research innovations have been made on applications of chitosan in biomedical applications. The book explores key topics, such as molecular weight, degree of deacetylation, and molecular geometry, along with an emphasis on recent advances in the field written by academic, industry, and clinical researchers. Chitosan in Biomedical Applications will be of interest to those in biomedical fields including the biomaterials and tissue engineering community investigating and developing biomaterials for biomedical applications, particularly graduate students, young faculty and others exploring chitosan-based materials. Provides methodology for the design, development and selection of chitosan in biomedical applications for particular therapeutic applications Includes illustrations demonstrating the mechanism of biological interaction of chitosan Discusses the regulatory aspects and demonstrates the clinical efficacy of chitosan

Nanoformulation Strategies for Cancer Treatment provides an up-to-date review on current developments and regulatory and clinical challenges in the field of nanopharmaceuticals and the effective treatment of diverse varieties of cancer. This important reference source is ideal for biomaterials scientists and pharmaceutical scientists working in the area of cancer diagnosis and therapy. Due to the high cost of traditional cancer treatment types, researchers have increasingly looked for new ways to augment the therapeutic performance of existing drug candidates. The use of nanotechnology-based approaches have gained significant momentum, thus leading to the launch of a series of new drug products.

As nanopharmaceuticals improve the therapeutic performance of cancer therapy drugs, but also provide opportunities for site-specific drug targeting in tumors, this work is a welcomed resource on the topics discussed.

Highlights the application of nanoformulations, including liposomes, nanoparticles and nanobiomaterials for targeted drug delivery to cancer cells Explores recent advances made using novel nanoformulations containing herbal drugs and biotechnology based therapeutic strategies for cancer treatment Assesses the regulatory hurdles that are necessary for the successful clinical translation of nanomedicines from the laboratory into the market

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.

Presents the progress made in cancer medicines from conventional to targeted therapy Covers the present state-of-the-art of cancer nanomedicines and upcoming therapeutic cancer vaccination Contains a focus on advanced nanomaterials that are utilized for encapsulation of nucleic acid, mRNA, DNA, siRNA

Nanostructured Drug Delivery Systems in Infectious Disease Treatment explores a broad range of promising approaches for the treatment of infectious diseases using the latest advancements in nanomedical technologies. The book opens with an introduction about infectious diseases and global burdens. There is also specific discussion and assessment of the global impact of viruses with an emphasis on COVID-19, Zika, and Ebola. Subsequent chapters provide detailed information about various novel nanotherapeutic strategies used for delivering drugs for the treatment of various types of viral, bacterial, and fungal disorders. This will be a valuable resource for graduates, researchers, industry professionals, and anyone working to tackle the challenges of delivering drugs in a more targeted and efficient manner for the treatment of infectious diseases.

Focuses on the application of different nanotechnology-based drug delivery systemsOffers information on how to design and develop the nanotechnology-based drug delivery systems and devices for the treatment of infectious disordersExplores challenges and regulatory concerns of nanomedicine in infectious disorders

This new volume, Nanomedicine for the Treatment of Disease: From Concept to Application, looks at the application of nanomedicines with a particular focus on their use in the treatment of diseases. The chapters in this volume, contributed by eminent scientists, researchers, and nanotechnologists from across the globe, highlight key advancements, challenges, and opportunities in the area of application of nanomedicines for disease treatment. They explore the design and development of therapeutic nanocarriers for targeting drugs for satiating the demands of disease treatment process. The volume explores the use nanomedicines for the diagnosis and treatment of a multitude various diseases and health conditions, including respiratory diseases, neurological disorders, genetic diseases, pulmonary fungal infections, neuroAIDS, cardiovascular disorders, gastric and colonic diseases, skin disorders, cancer, brain tumors, leishmaniasis and other visceral diseases, hypertension, and ocular diseases.

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding.This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

This new volume looks at the applications of biomarkers as important tools for herbal drug discovery, presenting research on phytoconstituents with advanced nanotechnological applications for healthcare benefits.Herbal drug discovery based on biomarkers is an emerging area in complementary and alternative medicine that has tremendous potential in healthcare. Conventional medications have limited efficacy and high toxicity, whereas herbal drugs are said to provide wide structural diversity that is not usually seen with conventional/synthetic drug molecules. Recognition of various herbal constituents, such as terpenoids, fatty acids, flavonoids and steroids, are well explored in the management and treatment of various disorders in this volume. These agents target various biomarkers such as nitric oxide (NO), cytokines, chemokines, adhesion molecules, NF- kβ, lipoxygenase (LOX), and arachidonic acid.Biomarkers as Targeted Herbal Drug Discovery: A Pharmacological Approach to Nanomedicines discusses phytoconstituent-based nanotherapeutics with applications for some specific health issues, such as arthritis, leishmanicidal, cardiovascular diseases, cancer, ocular disorders, etc.

This new volume, Nanomedicine for the Treatment of Disease: From Concept to Application, looks at the application of nanomedicines with a particular focus on their use in the treatment of diseases. The chapters in this volume, contributed by eminent scientists, researchers, and nanotechnologists from across the globe, highlight key advancements, challenges, and opportunities in the area of application of nanomedicines for disease treatment. They explore the design and development of therapeutic nanocarriers for targeting drugs for satiating the demands of disease treatment process. The volume explores the use nanomedicines for the diagnosis and treatment of a multitude various diseases and health conditions, including respiratory diseases, neurological disorders, genetic diseases, pulmonary fungal infections, neuroAIDS, cardiovascular disorders, gastric and colonic diseases, skin disorders, cancer, brain tumors, leishmaniasis and other visceral diseases, hypertension, and ocular diseases.

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding.This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

This new volume looks at the applications of biomarkers as important tools for herbal drug discovery, presenting research on phytoconstituents with advanced nanotechnological applications for healthcare benefits.Herbal drug discovery based on biomarkers is an emerging area in complementary and alternative medicine that has tremendous potential in healthcare. Conventional medications have limited efficacy and high toxicity, whereas herbal drugs are said to provide wide structural diversity that is not usually seen with conventional/synthetic drug molecules. Recognition of various herbal constituents, such as terpenoids, fatty acids, flavonoids and steroids, are well explored in the management and treatment of various disorders in this volume. These agents target various biomarkers such as nitric oxide (NO), cytokines, chemokines, adhesion molecules, NF- kβ, lipoxygenase (LOX), and arachidonic acid.Biomarkers as Targeted Herbal Drug Discovery: A Pharmacological Approach to Nanomedicines discusses phytoconstituent-based nanotherapeutics with applications for some specific health issues, such as arthritis, leishmanicidal, cardiovascular diseases, cancer, ocular disorders, etc.

The new book focuses on the use of natural active substances and nutraceuticals in nano-research for improved healthcare management and applications. It explores advanced nanomaterials that can be utilized for the encapsulation of nutrients, vitamins, and phytoconstituents for the treatment of cancer, psychotic and manic disorders, and chronic inflammation, such as arthritis and psoriasis, as well as for other healthcare issues, such as skin diseases and skin care, atherosclerosis, and more. The chapters discuss the remarkable advantages of using new bioactive and nutraceutical drugs, which offer improved solubility, bioavailability, simultaneous drug delivery, safety extension, long-term delivery, better dissemination of tissue macrophages, security against toxicity, increase in pharmacological activity, and enhanced physical and chemical protection.

Nanotechnology is opening up new avenues in all scientific and technological fields. Among the novel applications, bioactives and nutraceuticals are fast-growing areas of nano research for better healthcare solutions. A variety of nanoformulations, such as polymeric nanoparticles, nanocapsules, nanoemulsions, transferosomes and ethosomes, liposomes, lipospheres, and lipid polymer hybrid nanoparticles have proved valuable in bioactive delivery and food materials. Further, new herbal drugs and nutraceuticals are reported to have remarkable advantages over conventional formulations of plant actives and extracts, including enhanced solubility, bioavailability, multiple drug delivery, greater stability, sustained delivery, improved tissue macrophage distribution, protection from toxicity, enhancement of pharmacological activity and protection from physical and chemical degradation. This book focuses on the advanced nanomaterials that are utilized for the encapsulation of nutrients/vitamin/phytoconstituents, as well as their other healthcare benefits.

Nanotechnology is opening up new avenues in all scientific and technological fields. Among the novel applications, bioactives and nutraceuticals are fast-growing areas of nano research for better healthcare solutions. A variety of nanoformulations, such as polymeric nanoparticles, nanocapsules, nanoemulsions, transferosomes and ethosomes, liposomes, lipospheres, and lipid polymer hybrid nanoparticles have proved valuable in bioactive delivery and food materials. Further, new herbal drugs and nutraceuticals are reported to have remarkable advantages over conventional formulations of plant actives and extracts, including enhanced solubility, bioavailability, multiple drug delivery, greater stability, sustained delivery, improved tissue macrophage distribution, protection from toxicity, enhancement of pharmacological activity and protection from physical and chemical degradation. This book focuses on the advanced nanomaterials that are utilized for the encapsulation of nutrients/vitamin/phytoconstituents, as well as their other healthcare benefits.

Nanophytomedicine is a field that involves the application of nanomedicine-based systems to phytotherapy and phytopharmacology. This book assesses the clinical successes and failures of nanophytomedicine and also highlights emerging concepts in this field. The content is divided into three sections, the first of which describes core issues in the pharmaceuticals industry in connection with the successes, failures and prospects of nanophytomedicine. The second section highlights recent advances in phytomedicine formulation development based on nanotechnology approaches, while also discussing a variety of nanocarrier systems for the successful delivery of phytomedicines. Focusing on the clinical perspective, the third section addresses the current clinical status of nanophytomedicine as a single drug therapy or combinatorial drug therapy, pharmacovigilance, pharmacokinetics, drug interactions and toxicological profiles, while also providing concluding remarks on recent experimental findings, and considering ethical issues & regulatory challenges in nanophytomedicine.Given its scope, the book offers a valuable guide for early career researchers, young scientists, master level students, academics and industrial scientists working in various healthcare fields, e.g. the pharmaceutical and biological sciences, life sciences, biotechnology, biomedical engineering, and nanobiotechnology.

Nanophytomedicine is a field that involves the application of nanomedicine-based systems to phytotherapy and phytopharmacology. This book assesses the clinical successes and failures of nanophytomedicine and also highlights emerging concepts in this field. The content is divided into three sections, the first of which describes core issues in the pharmaceuticals industry in connection with the successes, failures and prospects of nanophytomedicine. The second section highlights recent advances in phytomedicine formulation development based on nanotechnology approaches, while also discussing a variety of nanocarrier systems for the successful delivery of phytomedicines. Focusing on the clinical perspective, the third section addresses the current clinical status of nanophytomedicine as a single drug therapy or combinatorial drug therapy, pharmacovigilance, pharmacokinetics, drug interactions and toxicological profiles, while also providing concluding remarks on recent experimental findings, and considering ethical issues & regulatory challenges in nanophytomedicine.Given its scope, the book offers a valuable guide for early career researchers, young scientists, master level students, academics and industrial scientists working in various healthcare fields, e.g. the pharmaceutical and biological sciences, life sciences, biotechnology, biomedical engineering, and nanobiotechnology.

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.

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.

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development.

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development.

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development.