Resultados de Pesquisa

INGLÊS

Pediatric Formulations - A Roadmap

~~175,73€~~ 140,58€ 20% IMEDIATO

portes grátis

 Since the first edition in 2014 pediatric drug development has expanded in several dimensions. This is not a â€œhow to formulateâ€œ textbook, but an attempt to equip the reader with necessary information on the technical, the regulatory, and the historical level.
INGLÊS

Antibody-Drug Conjugates - The 21st Century Magic Bullets For Cancer

~~158,34€~~ 126,67€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 <p>The field of antibody-drug conjugates (ADCs) has undergone remarkable advancements in recent years, marked by significant progress in both drug approvals and ongoing clinical development. Since the approval of the first ADC in 2010 (gemtuzumab ozogamicin, Mylotarg®), the landscape has expanded dramatically. Today, there are 11 FDA-approved ADCs, targeting a variety of cancers across multiple indications. The approved ADCs include a range of payloads, linkers, and antibodies, each optimized for a variety of specific therapeutic targets. The increasing diversity of ADCs reflects the growing potential of these innovative treatments to address a wide array of malignancies, from hematologic cancers to solid tumors.</p><p>This book aims to provide a comprehensive overview of the current state of the ADC field including the latest developments, challenges, and emerging trends, comprising expertise from a broad range of disciplines from basic research, industry, clinical practice and regulatory affairs. We explore not only the scientific and technical aspects of ADC design—such as payloads, linkers, and antibody selection—but also the developmental hurdles and regulatory complexities that influence the success of ADCs in clinical practice. Real-world examples of ADCs that have made it from the lab to the clinic offer invaluable insights into the trials and triumphs that shape this dynamic field. It is our hope that this book will serve as both a valuable resource for experts in the field and an accessible introduction for those new to the exciting world of ADCs.</p><p> </p>
INGLÊS

Bioequivalence Requirements In Various Global Jurisdictions

~~237,84€~~ 190,27€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 <p>An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions.</p><p>In view of the dynamic nature of regulatory requirements which are usually regularly updated, updating these requirements to remain current is an important necessity to provide such information to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products. The revised volume includes updated information based on recent guidances and guidelines from the respective regulatory agencies as well as important trends and descriptions relating to innovative approaches for bioequivalence assessment.</p>
INGLÊS

Sustainable Global Health Systems And Pharmaceutical Development

de Bhavishya Mittal

~~158,99€~~ 127,19€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 Still, a very high amount of resources are being spent on drug development from a societal perspective. Despite being an economically intense activity, the current state of drug product development makes a limited effort to integrate economics into product design and development.
INGLÊS

Drug Delivery To The Brain - Physiological Concepts, Methodologies And Approaches

~~216,29€~~ 173,03€ 20% IMEDIATO

portes grátis

 It contains methods descriptions for studying drug delivery, routes and approaches of administering drugs into the brain, the influence of disease, drug industry perspectives, and a primer on neuroanatomy and physiological considerations written specifically for drug delivery scientists.
INGLÊS

Formulating Poorly Water Soluble Drugs

~~297,40€~~ 237,92€ 20% IMEDIATO

portes grátis

 The objective of this third edition is to consolidate within a single text the most current knowledge, practical methods, and regulatory considerations pertaining to formulations development with poorly water-soluble molecules.
INGLÊS

3d Printing - Emerging Technologies And Functionality Of Polymeric Excipients In Drug Product Development

~~242,90€~~ 194,32€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 <div>This inclusive text describes <i>3D Printing</i> for pharmaceutical applications, including emerging 3D technologies. The book focuses on the functionality of the materials/biomaterials used for the preparation of dosage forms and devices, fundamentals for preparing these systems and novel applications using these additive manufacturing techniques. Also, the text includes clinical relevance and regulatory considerations for the future of personalized medicine.</div><div><br></div><div>Authored by experts with a broad range of experience, extensive insight into the science of <i>3D printing</i> technology used to produce these systems is provided. Highlighting viewpoints from the academic, polymer excipient, equipment, product development and regulatory communities, this comprehensive text compiles input from industry thought leaders to illustrate strategies and technologies for applying techniques of additive manufacturing for drug product and device development whilealso providing insight into the path forward for the technology in years to come. </div>
INGLÊS

Pharmaceutical Formulations For Older Patients

~~211,34€~~ 169,07€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 <p>Pharmaceutical formulation design affects patient acceptability/adherence and pharmacokinetics of the drug. This is particularly important for older patients because of the physiological changes due to ageing and clinical/social circumstances related to medicine taking.</p><p><br></p><p>This book provides a comprehensive review in the design of formulations to meet the needs of older patients. An overview of the key clinical, social and pharmaceutical factors affecting medication optimization, safety and acceptability in older adults is included, followed by patient-centric considerations including regulatory requirements, dosage form design and human factor studies.</p><p><br></p><p>Advanced pharmaceutical technologies are discussed for their potential use in older adults such as 3D printing, long-acting oral formulations and novel vaccine technologies. The unique focus of the book will be of interest to pharmaceutical scientists in both industryand academia in searching for better formulations for older patients.</p>
INGLÊS

Nanomedicines For The Prevention And Treatment Of Infectious Diseases

~~264,34€~~ 211,47€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 <p>The COVID-19 pandemic has altered the world and reiterated the perpetual need for the development of effective strategies for the prevention and treatment of infectious diseases. While globally prevalent infectious diseases receive extensive attention in terms of drug development and delivery, the neglected and/or emerging infectious diseases that affect developing countries are often overlooked. Additionally, the therapeutic efficacy of existing anti-infective agents is often limited due to sub-optimal biopharmaceutical properties, sub-therapeutic levels of the drugs at the infection site due to various physiological barriers, the expulsion of the drug by efflux transporters, and the emergence of drug-resistant strains.</p>From the commercialization of AmBisome® to the emergency authorization of mRNA-based vaccines, nanotechnology has played a vital role in the prevention and treatment of infectious diseases. More importantly, nanotechnology has enabled the effective utilization ofexisting armamentarium against infectious diseases leading to improved therapeutic outcomes with a concomitant reduction in the side effects associated with anti-infective agents. In particular, nanotechnology can bring about a paradigm shift in the management of neglected and emerging infectious diseases and may compensate for the lack of drug discovery efforts. While there are several books dedicated to pharmaceutical and/or biomedical applications of nanotechnology or nanotechnology for cancer therapy a comprehensive book focusing on the prevention and/or treatment of viral, bacterial, fungal, and parasitic infections is not available. This book addresses an unmet need in pharmaceutical and medical education.<p></p>This book provides a comprehensive and up-to-date overview of the latest advancements in nanomedicine, which show great potential for preventing and treating infectious diseases. Covering a wide range of topics, it explores various formulation strategies for combating microbial, fungal, parasitic, and viral infections. The book emphasizes the advantages of nano-scale vaccines over traditional ones and discusses their production. It also examines feasible treatment approaches for diseases like malaria, trypanosomiasis, candidiasis, Hepatitis B, HIV, and the ongoing COVID-19 pandemic. Additionally, it highlights the role of nano-adjuvants in vaccine development, as well as the use of peptide antibiotics and pulmonary delivery of drugs, which open up new possibilities in fighting infectious diseases. Furthermore, the book explores the critical role of nanomedicine in addressing veterinary parasitic infections. The emergence of nanotechnology has led to novel strategies for diagnosing, treating, and preventing parasitic infections in animals.<p></p><p>In summary, this book offers a comprehensive description of clinically viable and investigational nanotechnology-enabled medicines (nanomedicines) for the prevention and treatment of globally prevalent, neglected, and emerging infectious diseases.</p>
INGLÊS

Peptide Therapeutics - Fundamentals Of Design, Development, And Delivery

~~148,70€~~ 118,96€ 20% IMEDIATO

portes grátis

 This book explains how peptide-based drug design works, what steps are needed to develop a peptide-based therapeutic, and challenges in synthesis as well as regulatory issues.
INGLÊS

Ophthalmic Product Development - From Bench To Bedside

~~216,29€~~ 173,03€ 20% IMEDIATO

portes grátis

 The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products.
INGLÊS

Essentials Of Industrial Pharmacy

~~101,38€~~ 81,10€ 20% IMEDIATO

portes grátis

 Essentials of Industrial Pharmacy is an attempt to comprehensively present, in a single book, various pharmaceutical processes and equipment that are frequently used for production of pharmaceutical dosage forms, along with quality control tests of these dosage forms.
INGLÊS

Principles And Practices Of Lyophilization In Product Development And Manufacturing

~~198,09€~~ 158,47€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for<b> </b>characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, <i>Principles and Practice of Lyophilization Process and Product Development</i> contains an entire dedicated section on "Preservation of Biologicals" comprised of nine chapters written by experts and including case studies.
INGLÊS

Peptide Therapeutics - Fundamentals Of Design, Development, And Delivery

~~145,09€~~ 116,07€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 This book explains how peptide-based drug design works, what steps are needed to develop a peptide-based therapeutic, and challenges in synthesis as well as regulatory issues.
INGLÊS

Introduction To Bioanalysis Of Biopharmaceuticals

~~211,34€~~ 169,07€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 <div><p>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.</p></div><div> <p></p></div><div>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.<p></p></div><div><p> </p></div><div><p>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.</p></div>
INGLÊS

Formulating Poorly Water Soluble Drugs

~~290,84€~~ 232,67€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 The objective of this third edition is to consolidate within a single text the most current knowledge, practical methods, and regulatory considerations pertaining to formulations development with poorly water-soluble molecules.
INGLÊS

Drug Delivery To The Brain - Physiological Concepts, Methodologies And Approaches

~~211,34€~~ 169,07€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 It contains methods descriptions for studying drug delivery, routes and approaches of administering drugs into the brain, the influence of disease, drug industry perspectives, and a primer on neuroanatomy and physiological considerations written specifically for drug delivery scientists.
INGLÊS

Drug Delivery To The Brain - Physiological Concepts, Methodologies And Approaches

~~216,29€~~ 173,03€ 20% IMEDIATO

portes grátis

 It contains methods descriptions for studying drug delivery, routes and approaches of administering drugs into the brain, the influence of disease, drug industry perspectives, and a primer on neuroanatomy and physiological considerations written specifically for drug delivery scientists.
INGLÊS

Formulating Poorly Water Soluble Drugs

~~297,40€~~ 237,92€ 20% IMEDIATO

portes grátis

 The objective of this third edition is to consolidate within a single text the most current knowledge, practical methods, and regulatory considerations pertaining to formulations development with poorly water-soluble molecules.
INGLÊS

Essentials Of Industrial Pharmacy

~~98,71€~~ 78,97€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 Essentials of Industrial Pharmacy is an attempt to comprehensively present, in a single book, various pharmaceutical processes and equipment that are frequently used for production of pharmaceutical dosage forms, along with quality control tests of these dosage forms.
INGLÊS

Essentials Of Industrial Pharmacy

~~148,70€~~ 118,96€ 20% IMEDIATO

portes grátis

 Essentials of Industrial Pharmacy is an attempt to comprehensively present, in a single book, various pharmaceutical processes and equipment that are frequently used for production of pharmaceutical dosage forms, along with quality control tests of these dosage forms.
INGLÊS

Ophthalmic Product Development - From Bench To Bedside

~~211,34€~~ 169,07€ 20% IMEDIATO

DISPONIBILIDADE IMEDIATA

 The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products.
INGLÊS

Translating Molecules Into Medicines - Cross-Functional Integration At The Drug Discovery-Development Interface

~~337,96€~~ 270,37€ 20% IMEDIATO

portes grátis

 Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field.
INGLÊS

Ophthalmic Product Development - From Bench To Bedside

~~216,29€~~ 173,03€ 20% IMEDIATO

portes grátis

 The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products.
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