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  • 1
    Online Resource
    Online Resource
    Cham :Springer International Publishing :
    Keywords: Pharmacology. ; Medical sciences. ; Drug development. ; Medicine Research. ; Biology Research. ; Pharmaceutical chemistry. ; Biometry. ; Toxicology. ; Pharmacology. ; Preclinical Research. ; Biomedical Research. ; Pharmaceutics. ; Biostatistics. ; Medical Toxicology.
    Description / Table of Contents: Introduction-.What is a DMC?-. Is a DMC required?-. Who is On the DMC?-. What are the Legal and Ethical Aspects of DMC?-. How does the DMC work with SDAC and Sponsor and External Groups ? -- What Does a DMC Meeting Look Like -- What data is used for DMC outputs and who programs? -- What is Included in DMC Outputs? -- What does the DMC final DMC outputs look like and how is it delivered? -- What Types of Safety Outputs Does the DMC Receive? -- What types of efficacy outputs does the DMC receive? -- What types of other outputs does the DMC receive? -- What About In-Between DMC Meetings -- What types of formal interim analyses does the DMC review? -- What does the paperwork from meetings look like? -- How does the DMC assess risk-benefit for their decision making? -- What are some examples? -- Conclusions.
    Abstract: This book provides an overview of Data Monitoring Committees - what was done in the past, what is currently being done, and thoughts on improvements for the future. Previous works focused primarily on large cardiovascular studies (where DMCs originated more than 30 years ago) but updated references are needed that discuss smaller, more flexible studies in areas such as oncology. The authors have attended ~800 DMC meetings from ~200 distinct studies across all areas of clinical studies (oncology, rheumatology, rare diseases, cardiology, immunology, etc.) This wide range of expertise will be used, as well as the expertise that comes from working with virtually every large biotech/pharma and CRO for DMC work. The reader of the book will know when DMCs are needed or helpful, how to form the DMC, how to work with external CROs and with sponsor teams and the DMC to create needed DMC outputs, how the DMC meetings are conducted, and - especially for DMC members - what are considerations within the Closed Session to review safety/efficacy outputs to assess risk/benefit to make appropriate recommendations that protect the patient safety and trial integrity. This is a practical hands-on book on how to decide if a DMC is necessary, how to form the DMC, how to smoothly create the necessary materials for the DMC and have smooth running DMC meetings. There is no specialized training in school about how DMCs work - frequently people may have been in industry for many years without ever needing to work with a DMC. This book is the helpful reference for those new to these DMCs. The DMC work is critical to be correctly implemented as the implications of it are so great. This book provides the following: Thorough instructions on the steps needed to form and implement a Data Monitoring Committee for clinical trial evaluation; Includes practical and hands-on information on DMC implementation; Discusses a wide range of clinical trial – by phase and therapeutic area.
    Type of Medium: Online Resource
    Pages: XII, 111 p. 1 illus. , online resource.
    Edition: 1st ed. 2023.
    ISBN: 9783031287602
    DDC: 615
    Language: English
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  • 2
    Keywords: Pharmacology. ; Pharmaceutical chemistry. ; Cytology. ; Toxicology. ; Immunology. ; Pharmacology. ; Pharmaceutics. ; Cell Biology. ; Toxicology. ; Immunology.
    Description / Table of Contents: Part I Anatomy, Physiology and Pharmacology of Macrophages -- Introduction to Anatomy and Physiology of Macrophages from Drug Delivery Perspective -- Introduction to Pharmacology of Macrophages from Drug Delivery Perspective -- Mechanisms and Ways of Macrophage Delivery -- Macrophage Associated Disorders: Pathophysiology, Treatment Challenges and Possible Solutions -- Understanding Macrophage Associated Diseases and Applications of Nano Drug Delivery Systems -- Part II Polymeric Nanoparticles for Macrophage Targeting -- Targeting of Macrophages: Basic and therapeutic Role of Polymeric Nanoparticles -- Polymeric Nanoparticles Based Drug and Gene Delivery to Macrophages -- Surface Modification of Nanoparticles for Macrophage Targeting -- Part III Lipid Nanoparticles for Macrophage Targeting -- Liposomes as Delivery System for Macrophage Targeting -- Solid Lipid Nanoparticles Based Drug and Gene Delivery to Macrophages -- In vivo Fate of Colloidal Carriers Undergoing Macrophage Targeting -- Nanoparticle-based Theranostics for Macrophage-associated Diseases -- Part IV Targeting Macrophages for Treatment of Various Diseases -- Tumor Associated Macrophages as Therapeutic Target for Drug/immune Therapy of Cancer -- Macrophage Targeting for Therapy of Autoimmune Diseases -- Macrophage Targeting for Therapy of Cardiovascular Diseases (CVD) -- Macrophage targeting for therapy of intracellular infections -- Targeting Drugs and Nucleic Acids to Macrophages for Therapy of Inflammatory Diseases -- Macrophage Targeted Chemotherapy for Tuberculosis and other Respiratory Disease. -- Part V Specific Formulations and Clinical Trials on Macrophage Targeted Delivery -- Nano- and Microparticles Based Dry Powder Inhalers for Pulmonary Macrophage Drug Delivery -- Recent Trends in Clinical Studies on Macrophage Targeted Delivery -- Future Directions and Challenges in Macrophage Targeting. .
    Abstract: The proposed book is envisioned for the nascent and entry-level researchers who are interested to work in the field of drug delivery and its applications specifically for macrophage targeting. Macrophages have gained substantial attention as therapeutic targets for drug delivery considering their major role in health and regulation of diseases. Macrophage-targeted therapeutics have now added significant value to the lives and quality of life of patients, without undue adverse effects in multiple disease settings. We anticipate examining and integrating the role of macrophages in the instigation and advancement of various diseases. The major focus of the book is on recent advancements in various targeting strategies using delivery systems or nanocarriers followed by application of these nanocarriers for the treatment of macrophage associated disorders. Macrophage Targeted Delivery Systems is primarily targeted to Pharmaceutical Industry & Academia, Medical & Pharmaceutical Professionals, Undergraduate & Post graduate students and Research Scholars, Ph.D, post docs working in the field of medical and pharmaceutical sciences.
    Type of Medium: Online Resource
    Pages: XVIII, 556 p. 76 illus., 73 illus. in color. , online resource.
    Edition: 1st ed. 2022.
    ISBN: 9783030841645
    DDC: 615
    Language: English
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  • 3
    Keywords: Pharmacology. ; Toxicology. ; Pharmaceutical chemistry. ; Pharmacology. ; Toxicology. ; Pharmaceutics.
    Description / Table of Contents: Therapeutic and toxic concentration of drugs in biological matrices -- Analytical techniques for therapeutic drug monitoring and clinical toxicology -- Plasma therapeutic drug monitoring and clinical toxicology -- Dried blood spots in therapeutic drug monitoring and toxicology -- The role of artificial intelligence in therapeutic drug monitoring and clinical toxicity -- Therapeutic drug monitoring and optimal pharmacotherapy with medicines of narrow therapeutic index -- Therapeutic drug monitoring (TDM) and toxicological studies in alternative biological matrices -- Analyzing data from therapeutic drug monitoring, pharmacokinetics, and clinical toxicology studies -- Reducing toxicity in critically ill patients by using therapeutic drug monitoring -- Quality assurance of samples for therapeutic drug monitoring and clinical toxicology -- Therapeutic drug monitoring and toxicology of anticancer drugs -- Therapeutic drug monitoring and toxicology of immunosuppressant -- Therapeutic drug monitoring and toxicology: relevance of measuring metabolites -- Recent advances in nanosensors for Therapeutic Drug Monitoring (TDM) -- Organ toxicity by immunosuppressive drugs in solid organ transplantation -- Artificial intelligence-based techniques to assess drug toxicity in drug induced liver injury (DILI) disease -- Drug dose and therapy individualization -- Models for drug individualization: patient to population level -- Toxicity evaluation of nanomedicine -- Biochemical indices of drug toxicity -- Therapeutic drug monitoring and clinical toxicology: challenges and future directions.
    Abstract: This book gives an overview of therapeutic drug monitoring (TDM) and its clinical application. It also highlights recent advances in toxicological studies, as they relate to therapeutic drug monitoring. This is one of the few books available on the market that covers TDM. Therapeutic drug monitoring (TDM) is a clinical decision-making tool that enables dosage regimen adjustments based on clinical and laboratory measurements. TDM not only involves the measuring of drug concentrations but also interpretation of the results. There is a strong correlation between drug concentrations in body fluids and outcome than between dose and outcome. The chapters include coverage of analytical techniques, pharmacokinetics, therapeutic indices, artificial intelligence and recent advances in toxicological studies. The book fills a gap in published literature and provides reliable information on; Analytical techniques in TDM and clinical toxicology TDM and pharmacokinetic studies TDM of drugs with narrow therapeutic indices Artificial intelligence in TDM and clinical toxicology Future directions and challenges .
    Type of Medium: Online Resource
    Pages: XVIII, 381 p. 43 illus., 41 illus. in color. , online resource.
    Edition: 1st ed. 2022.
    ISBN: 9783031123986
    DDC: 615
    Language: English
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  • 4
    Keywords: Pharmacology. ; Toxicology. ; Pharmaceutical chemistry. ; Medicinal chemistry. ; Natural products. ; Pharmacology. ; Toxicology. ; Pharmaceutics. ; Medicinal Chemistry. ; Natural Products.
    Description / Table of Contents: Chapter 1: Achillea biebersteinii Afan -- Chapter 2: Aesculus hippocastanum L. -- Chapter 3: Berberis crataegina DC. -- Chapter 4: Calendula officinalis L. -- Chapter 5: Camellia sinensis (L.) Kuntze -- Chapter 6: Capsella bursa-pastoris (L.) Medik. -- Chapter 7: Capsicum annuum L. -- Chapter 8: Cedrus libani A.Rich. -- Chapter 9: Chelidonium majus L. -- Chapter 10: Cichorium intybus L. -- Chapter 11: Cistus laurifolius L. -- Chapter 12: Coriandrum sativum L. -- Chapter 13: Cornus mas L. -- Chapter 14: Curcuma longa L..-Chapter 15: Cydonia oblonga Mill. -- Chapter 16: Cynara scolymus L. -- Chapter 17: Equisetum arvense L. -- Chapter 18: Foeniculum vulgare Mill. -- Chapter 19: Fraxiınus ornus L. -- Chapter 20: Fumaria officinalis L. -- Chapter 21: Helichrysum plicatum DC. -- Chapter 22: Hyoscyamus niger L. -- Chapter 23: Juglans regia L. -- Chapter 24: Laurus nobilis L. -- Chapter 25: Liquidambar orientalis Miller -- Chapter 26: Matricaria chamomilla L. -- Chapter 27: Melissa officinalis L. -- Chapter 28: Momordica charantia L. -- Chapter 29: Nigella sativa L. -- Chapter 30: Olea europaea L. -- Chapter 31: Papaver somniferum L. -- Chapter 32: Rheum ribes L. -- Chapter 33: Rosa canina L. -- Chapter 34: Rosmarinus officinalis L. -- Chapter 35: Silybum marianum L. Gaertn. -- Chapter 36: Urtica dioica L -- Chapter 37: Valeriana officinalis L. -- Chapter 38: Viburnum opulus L.
    Abstract: This book collects information about the most popular ethnomedicinal plants, which are common in Turkey and around the world. It presents the ethnopharmacological records, in vivo and in vitro studies, side effects, chemical compositions and clinical studies of these medicinal plants. Its special focus is on the novel drug targets for disease and their possible mechanisms of action. It covers botanical descriptions the status of the plants, and food or drug interactions including precautions and warnings about the plants and the available market products. It provides an explanation of recorded and known plant administration dosages. Also, the gap between the traditional practice and scientific/clinical evidences in the use of ethnomedicinal plant is acknowledged. It is well known that traditional knowledge of the use of the medicinal plants in therapy is an important resource for the discovery of novel treatment options and drug targets. The main purpose of this book is to draw attention to ethnomedicinal plant species. Data on the therapeutic potentials of these medicinal plants can now be accessed from a single source. It provides an important resource for future research opportunities for harnessing the full potential of these plants.
    Type of Medium: Online Resource
    Pages: XII, 588 p. 119 illus., 43 illus. in color. , online resource.
    Edition: 1st ed. 2022.
    ISBN: 9783031077531
    DDC: 615
    Language: English
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  • 5
    Online Resource
    Online Resource
    Singapore :Springer Nature Singapore :
    Keywords: Pharmacology. ; Drug delivery systems. ; Biologicals. ; Biopharmaceutics. ; Toxicology. ; Biotechnology. ; Pharmacology. ; Drug Delivery. ; Biologics. ; Toxicology. ; Biotechnology.
    Description / Table of Contents: Chapter 1. Traditional Medical System (TMS) for Sustainable Healthcare in India -- Chapter 2. Modern Drug Discovery and Development for TB- The India Narrative -- Chapter 3. Indian Discovery Effort in the Quest of Novel Antibiotics -- Chapter 4. New Drug Discovery and Development in India to Counter Malaria -- Chapter 5. Modern Drug Discovery and Development in the area of Leishmaniasis -- Chapter 6. Modern Drug Discovery and Development: Diabetes and lifestyle disorders Part I – Introduction to Diabetes and Prevalence in India -- Chapter 7. Modern Drug Discovery and Development: Diabetes and lifestyle disorder Part II Type 2 Diabetes Mellitus: Marketed drugs and mechanisms -- Chapter 8. Modern Drug Discovery and Development: Diabetes and lifestyle disorders Part III Anti-diabetes research in India: Contributions from industrial organizations -- Chapter 9. Modern Drug Discovery and Development: Diabetes and lifestyle disorders Part IV Indian Academia Tryst with Cardio-metabolic Drug Discovery and Development -- Chapter 10. Modern drug discovery and development in the area of Cancer: Indian context -- Chapter 11. Biopharmaceutical development in India: recommendations on collaboration and innovation to enable affordable healthcare -- Chapter 12. Regulatory requirements and Quality Standards in India’s Clinical Trials Journey -- Chapter 13. Indian Pharma Perspective: New Drug Discovery and Development- Indian Pharmaceutical Industry.
    Abstract: Over the years, India has attained a prominent global position in the manufacture of Generic Drugs. This success can be attributed to its synthetic organic chemistry and chemical engineering strengths, nurtured by the timely policies of the Government of India. However, breakthrough successes in New Drug Discovery have remained elusive, despite the brilliant and sustained efforts of many Indian researchers and Pharma establishments. The Indian National Science Academy thought it appropriate to document India’s New Drug Discovery Research (NDDR) journey to date. Gathering contributions from prominent researchers in the Indian Pharma Industry and Academia, this book highlights their efforts, achievements, and the status quo of Indian NDDR. .
    Type of Medium: Online Resource
    Pages: XIII, 376 p. 191 illus., 44 illus. in color. , online resource.
    Edition: 1st ed. 2021.
    ISBN: 9789811580024
    DDC: 615
    Language: English
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  • 6
    Online Resource
    Online Resource
    Cham :Springer International Publishing :
    Keywords: Pharmacology. ; Pharmaceutical chemistry. ; Medicinal chemistry. ; Toxicology. ; Natural products. ; Pharmacology. ; Pharmaceutics. ; Medicinal Chemistry. ; Toxicology. ; Natural Products.
    Description / Table of Contents: Section I: General, Identity and Taxonomy -- The genus Phoma: What we know and what we need to know? -- Taxonomical evaluation of Phoma- history of classification, current status and future directions -- Section II: Diversity, Diseases and Host Range -- Phoma on medicinal and aromatic plants -- Diseases of fruits, tubers, and seeds caused by Phoma sensu lato species complex -- Overview of Phoma-like fungi on important legumes (Papilionaceous plants) -- Diseases of vegetables caused by Phoma spp -- Phoma diseases: identification, epidemiology and strategies for management -- Major plant diseases caused by Phoma sensu lato species and their integrated management strategies -- Phoma as an infectious pathogen in medical practice -- Section III: Secondary metabolites and Bioactivities -- Fruitful decade of Phoma secondary metabolites from 2011 to 2020: Chemistry, chemical diversity and biological activities -- Bioactive secondary metabolites from endophytic Phoma spp -- The genus Phoma: a review of its potential bioactivities, implications and prospects -- Bioherbicidal activity of Phoma macrostoma -- New technologies for the formulation of secondary metabolites produced by Phoma sp. for biological control of weeds -- Biological management of plant diseases by non-pathogenic Phoma spp -- Plant growth promoting Phoma spp -- Section IV:Nanotechnology and Fossil records of Phoma -- Potential role of Phoma spp. for mycogenic synthesis of Silver nanoparticles -- In situ occurrence of Phomites Fritel in the phyllosphere of ancient Siwalik forests of eastern Himalaya during the Mio-Pleistocene.
    Abstract: Given novel infectious diseases such as COVID-19 and antibiotic resistance new antimicrobial discovery is an important research area. Considering that nature is a vast source of bioactive molecules with antimicrobial activity, the main aim of this book is to present a comprehensive outlook of current research in the field of natural antimicrobials. It discusses the antimicrobial activity of medicinal plants, beehives, and mushrooms with a global coverage of antimicrobial agents from rich forests of Brazil (Amazon), North-Eastern forests of Peru, Argentina, Colombia, India, Bangladesh, Nepal, Middle East, Turkey, Croatia, Greece, Germany and Russia. The book covers the results of the in vitro screening of antimicrobial activities of extracts and isolated compounds from natural origins. It is divided into three sections: i) Section I, includes natural antimicrobials from plants; ii) Section II incorporates antimicrobial agents/secondary metabolites from plants, and (iii) Section III focuses on antimicrobials from mushrooms, beehive and delivery systems for different types of antimicrobials. Promising Antimicrobials From Natural Products is immensely useful for post graduate students, researchers in plant science, microbiology, biotechnology, pharmacology, pharma companies and those who are interested in herbal, eco-friendly, cost-effective and sustainable antimicrobials. Contains results of in vitro screening of extracts and isolated compounds Focuses on delivery systems Covers antimicrobial medicinal plants of Brazil (Amazon), North-Eastern forests of Peru, Argentina, Colombia, India, Bangladesh, Nepal, Middle East, Turkey, Croatia, Greece, Germany and Russia.
    Type of Medium: Online Resource
    Pages: XIII, 451 p. 94 illus., 28 illus. in color. , online resource.
    Edition: 1st ed. 2022.
    ISBN: 9783030835040
    DDC: 615
    Language: English
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