The definitive compendium of bioassay procedures and applications

A virtual encyclopedia of key bioassay protocols, this up-to-date, essential resource reviews the methods and applications of bioassays that quantify drug activity and evaluate the validity of pharmacological models.

Demonstrating the specific ways in which various pharmaceutical bioassays interpret the activity of drug molecules, the book covers the evaluation and screening of drug compounds in a wide spectrum of therapeutic categories.

Throughout, the authors use various models to link experimental observations with findings that clarify the effect of drug compounds on cellular biology and measure the pharmacological activity of chemical substances. This provides an important technological platform for successful drug research and clinical therapy, making "Pharmaceutical Bioassays" an ideal sourcebook for pharmacologists, pharmaceutical and medical researchers, analytical chemists, toxicologists, and students.

Just as a fundamental knowledge of pharmaceutical bioassays is vital to understanding how bioactive agents and new drugs are defined, discovered, and developed, so too is this indispensable reference, which:

Offers a complete reference on pharmaceutical bioassays and their specific applications in the assessment of therapies for cancer, Alzheimer's, diabetes, epilepsy, inflammation, antimalarials, pharmacogenomics, and other major therapeutic areas

Covers bioassays that measure toxicity, including those for chemical toxicity and hepatoxicity--a particularly significant consideration in the development of safe and tolerable medications

Highlights clinically relevant methods, ideas, and techniques to support any pharmaceutical researcher

Suggests guidelines and systems to enhance communication between pharmacologists, chemists, and biologists

Provides an informative analysis of pharmaceutical bioassay technologies and lab applications

Recent research in science establishes a direct relation between human gut and skin. Several species of live microbes inhabit the human skin and intestines which far outnumbers the mammalian cells in the human body. Research interest of Nextgen scientists is focused on beneficially harnessing this microbial population to address skin disorders like acne, rosacea, eczema, premature aging, and skin cancer which are established to be a result of skin-microbiome dysbiosis. This volume highlights evidence-based endeavours of the scientific community in this sector. Currently there is no concrete literature which gives a detailed vision on the relationship between gut microbiota and skin related disorders. This volume is an attempt to put together available data in the area and demonstrate usefulness of probiotics as a new therapeutic option for management of these skin diseases which currently show poor prognosis, high cost of treatment and compromised quality of life of the patient.

This book presents an overview of the current status of translating the RNAi cancer therapeutics in the clinic, a brief description of the biological barriers in drug delivery, and the roles of imaging in aspects of administration route, systemic circulation, and cellular barriers for the clinical translation of RNAi cancer therapeutics, and with partial content for discussing the safety concerns. It then focuses on imaging-guided delivery of RNAi therapeutics in preclinical development, including the basic principles of different imaging modalities, and their advantages and limitations for biological imaging. With growing number of RNAi therapeutics entering the clinic, various imaging methods will play an important role in facilitating the translation of RNAi cancer therapeutics from bench to bedside. RNAi technique has become a powerful tool for basic research to selectively knock down gene expression in vitro and in vivo. Our scientific and industrial communities have started to develop RNAi therapeutics as the next class of drugs for treating a variety of genetic disorders, such as cancer and other diseases that are particularly hard to address with current treatment strategies. Key Features Provides insight into the current advances and hurdles of RNAi therapeutics. Accelerates RNAi, miRNAs, and siRNA drug development for cancer therapy from bench to bedside. Addresses various modifications and novel delivery strategies for miRNAs, piRNAs and siRNA delivery in anticancer therapeutics. Explores the need for the interaction of hematologists,cell biologists, immunologists, and material scientists in the development of novel cancer therapies. Describes the current status of clinical trials related to miRNA and siRNA-based cancer therapy Presents remaining issues that need to be overcome to establish successful therapies.

We have surpassed the omics era and are truly in the Age of Molecular Therapeutics. The fast-paced development of SARS-CoV-2 vaccines, such as the mRNA vaccines encoding the viral spike protein, demonstrated the need for and capability of molecular therapy and nanotechnology-based solutions for drug delivery. In record speed, the SARS-CoV-2 viral RNA genome was sequenced and shared with the scientific community, allowing the rapid design of molecular therapeutics. The mRNA vaccines exploit the host cell endoplasmic reticulum to produce viral spike proteins for antigen presentation and recognition by the innate and adaptive immune system. Lipid nanoparticles enable the delivery of the fragile, degradation-sensitive nucleic acid payloads. Molecular-based therapeutics and nanotechnology solutions continue to drive the scientific and medical response to the COVID-19 pandemic as new mRNA, DNA, and protein-based vaccines are developed and approved and the emergency use approved vaccines are rapidly manufactured and distributed throughout the globe. The need for molecular therapies and drug delivery solutions is clear, and as these therapies progress and become more specialized there will be important advancements in organelle targeting. For example, using organelle targeting to direct lipid nanoparticles with mRNA payloads to the endoplasmic reticulum would increase the efficacy of mRNA vaccines, reducing the required dose and therefore the biomanufacturing demand. Likewise, improving the delivery of DNA therapeutics to the nucleus would improve efficacy. Organelles and molecules have always been drug targets, but until recently we have not had the tools or capability to design and develop such highly specific therapeutics. Organelle targeting has far-reaching implications. For example, mitochondria are central to both energy production and intrinsic apoptosis. Effectively targeting and manipulating mitochondria has therapeutic applications for diseases such as myopathies, cancer, neurodegeneration, progerias, diabetes, and the natural aging process. The SARS-CoV-2 vaccines that exploit the endoplasmic reticulum (for mRNA vaccines) and the nucleic translational process (DNA vaccines) attest to the need for organelle and molecular therapeutics. This book covers the status, demand, and future of organelle- and molecularly targeted therapeutics that are critical to the advancement of modern medicine. Organelle and molecular targeting is the drug design and drug delivery approach of today and the future; understanding this approach is essential for students, scientists, and clinicians contributing to modern medicine.

An integrated approach to provide information about all aspects of cancer biology, diagnosis and therapy. Covers both conventional and emerging tools/ techniques applicable in cancer screening and diagnosis. Covers the mechanisms of conventional and emerging anticancer drugs and therapies. Provides insights about personalized medicine based approach in cancer diagnosis and therapy.

The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a "one of a kind" contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.

Describes 'real life' examples in Medicinal Chemistry. Integrates the use of physical, chemical, and biological concepts that are important in drug design. Highlights the "ips" and "downs" that come with drug discovery. Aims to inspire students who may be struggling with the challenges and thought process in drug design. Intends to be an excellent companion text, illustrating real life experiences, for graduate and postgraduate students.

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as among clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence. This book lays out a path toward bridging some of these gaps. It offers ? A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges ? A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1) ? Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs: ? A perspective on the role of the intention-to-treat principle ? Examples and case studies from various areas ? Example code in SAS and R ? A connection with causal inference ? Implications and methods for analysis of longitudinal trials with missing data Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters <232>, <233>, and <2232>, together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials. It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters <232> <233> and <2232> and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter <233>, including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Phylogenetic presentation of medicinal plants and a chemotaxonomical rationale of antiviral, antibacterial, and antifungal action. Discusses chemical structure-activity relationship, pharmacokinetics, and oral bioavailability of antimicrobial principles Introduces the molecular mechanism of natural products on viruses, bacteria, and fungi. Contains a selection of botanical plates and useful bibliographic references A useful research tool for postgraduates, academics, and the pharmaceutical, herbal, or nutrition industries.

Phylogenetic presentation of medicinal plants and a chemotaxonomical rationale of antiviral, antibacterial, and antifungal action. Discusses chemical structure-activity relationship, pharmacokinetics, and oral bioavailability of antimicrobial principles Introduces the molecular mechanism of natural products on viruses, bacteria, and fungi. Contains a selection of botanical plates and useful bibliographic references A useful research tool for postgraduates, academics, and the pharmaceutical, herbal, or nutrition industries.

Covers four pillars of safety statistics: cross-disciplinary scientific engagement, effective and efficient operational process, visual analytics, and intelligent data architecture Links safety monitoring to benefit risk evaluation Presents an emerging topic that links to ICH E19 and TransCelerate safety efforts

Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs can speed up the patient enrolment, thus resulting in quicker drug development and obtaining faster approval of the drug globally. After the publication of the editors' first volume on this topic, there have been new developments on MRCTs. The International Council for Harmonisation (ICH) issued ICH E17, a guideline document on MRCTs, in November 2017, laying out principles on MRCTs. Beyond E17, new methodologies have been developed as well. Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 collects chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. In addition, in contrast to the first book, new perspectives are brought to MRCT from regulatory agencies. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. It will also be especially helpful for statisticians in regulatory agencies, and medical research institutes. This book is comprehensive across the MRCT topic spectrum, including Issues regarding ICH E17 Implementation MRCT Design and Analysis Methodologies Perspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industry Many examples of real-life applications based on actual MRCTs.

Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval. Key Features: Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA's current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time. This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.

This third volume in the successful 'Drug Discovery in Infectious Diseases' series is the first to deal with drug discovery in helminthic infections in human and animals. The result is a broad overview of different drug target evaluation methods, including specific examples of successful drug development against helminthes, and with a whole section devoted to vaccine development.
With its well-balanced mix of high-profile contributors from academia and industry, this handbook and reference will appeal to a wide audience, including parasitologists, pharmaceutical industry, epidemiologists, and veterinary scientists.

Provide readers and front line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements Covers basic quality concepts and the elements of vendor's assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies Provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry Provides ready to use regulatory documentation, e.g. letter of commitment, Questionnaire, SOP etc. required for API and Packaging Materials contract Provided material can be easily tailored to incorporate changes to add in-house vendor's qualification requirements

This publication is based on peer-reviewed manuscripts from the 2019 Conference on Drug Design & Discovery Technologies (CDDT) held at Ramaiah University of Applied Sciences, India. Providing a wide range of up to date topics on the latest advancements in drug design and discovery technologies, this book ensures the reader receives a good understanding of the scope of the field. Aimed at scientists, students, regulators, academics and consultants throughout the world, this book is an ideal resource for anyone interested in the state of the art in drug design and discovery.

Recombinant protein drugs are intimately associated with the impressive success story of the Biotech Industry during the past thirty years, some of them belonging to the most successful pharmaceutical products. More than thirty different proteins are available for a variety of clinical applications, over 300 proteins are presently being evaluated in clinical trials. In this new volume of the MDT series, historical, technical and clinical aspects of recombinant protein drug discovery and development are presented, covering past, present and future highlights. Leading scientists and co-founders of early Biotech companies describe technical breakthroughs and the fascinating story of pioneering discoveries, as well as the long way of translating them into products and business. Therefore, this book represents an exciting documentation of the beginning of a new era in the pharmaceutical industry. In addition, scientists from basic research, clinic and industry actively involved in new developments discuss...

Provides information about the different surfactants. Describes constraints in production and novel production strategies. Includes application oriented aspects of biosurfactants in various fields such as agriculture, Environmental, Pharmaceutical, and Food industry. Authored by experts in the field of biosurfactants.

Describes the ways Vitamin C can inhibit, perturb or retard the growth and spread of cancer through changing the ways cancers respond to different doses and treatmentsSumarizes the results of clinical trialsOutlines therapeutical usesChapters by an international team of researchers.

Withania is a genus of the nightshade family of flowering plants distributed in the subtropical regions from the Mediterranean to South East Asia. Only two species, W. somnifera and W. coagulans, are found in India. The most common species is W. somnifera (WS), which occurs naturally in the subtropical regions from the Mediterranean through Africa to the Middle East, the Indian Continent, Sri Lanka, South East Asia, subtropical America and Australia. It is a perennial shrub that grows to 75 cm (.75 m) tall with tomentose branches, oval yellowish green leaves, orange red berries and a papery calyx, and it survives harsher climatic conditions. In Ayurveda it is believed the plants which survive harsh conditions have strong healing and tonification properties. The main bioactive phytoconstituents of WS are withanolides (steroidal lactones), alkaloids, flavonoids, sterols, phenolics and others. Among the various withanolides, withanolide A, withaferin A, withanone and withanolide D are the most abundant, having various activities. WS is a wonder herb with a broad spectrum of pharmacological properties, such as antioxidant, antidepressant, aphrodisiac, antiulcerogenic, antivenom, anti-inflammatory, antiarthritic, anticancer, antiparasitic, antimicrobial, anticancerous, antidiabetic, antitumor, hemopoetic neuroregenerative, immunomodulatory, cardioprotective, radio-sensitizing, rejuvenating, antistress, sedative, hypoglycemic, thyroprotective, adaptogenic, antispasmodic, immunomodulatory, immunostimulant and antiaging properties. The simultaneous quantitative analysis of six major bioactive withanolides in five varieties of WS and in different plant parts (root, stem and leaf) of WS was accomplished. This method is also applicable to control the quality of commercially formulated products which contain WS bioactive compounds. Results indicated the WS variety NMITLI-135 showed the maximum abundance of withanolides at pH 8.5, EC-0.5 dS m 1, ESP-13 in sodic soil. Our results showed this readily available, rapid and reliable method is suitable for the routine analysis and effective quality control of raw materials and finished products. FEATURES Presents a collection of Ayurvedic features and scientific analytical and pharmacological evidence of important medicinal plants of Withania somnifera Useful for natural product researchers, faculty, students and herbal product manufacturers Uses advanced hyphenated techniques for assessing phytoconstituents

Recent Advances in the Science of Cannabis describes progress in a variety of significant areas of cannabis science. This unique book covers topics in cultivation and secondary metabolites, aroma and chemotypes, cannabinoid structures, physiology and pharmacology, as well as the development of unique topical products. State-of-the-art analytical methods and instrumentation are covered, including current developments in mass spectrometry and chromatography, as well as microbial testing. Given the popularity of smoking and vaporizing cannabis, the chemistry of vaping cannabinoid and terpene concentrates is also presented, along with emerging regulatory issues. Key Features: A guide to emerging modern cannabis technology in a dynamic regulatory climate and appealing to both novices and specialists. Building upon pioneering studies of terpene and cannabinoid chemistry, this distinctive volume describes current best practices, technological breakthroughs and historical context. Written by researchers in industry and academia, a greater understanding of the risks of exposure to emissions from vaping or dabbing cannabis concentrates is provided here. A selection of the book content reviewing Thermal Degradation of Cannabinoids and Cannabis Terpenes has been included in "Hot 2021" RSC Advances.

Confidence Intervals for Discrete Data in Clinical Research is designed as a toolbox for biomedical researchers. Analysis of discrete data is one of the most used yet vexing areas in clinical research. The array of methodologies available in the literature to address the inferential questions for binomial and multinomial data can be a double-edged sword. On the one hand, these methods open a rich avenue of exploration of data; on the other, the wide-ranging and competing methodologies potentially lead to conflicting inferences, adding to researchers' confusion and frustration and also leading to reporting bias. This book addresses the problems that many practitioners experience in choosing and implementing fit for purpose data analysis methods to answer critical inferential questions for binomial and count data. The book is an outgrowth of the authors' collective experience in biomedical research and provides an excellent overview of inferential questions of interest for binomial proportions and rates based on count data, and reviews various solutions to these problems available in the literature. Each chapter discusses the strengths and weaknesses of the methods and suggests practical recommendations. The book's primary focus is on applications in clinical research, and the goal is to provide direct benefit to the users involved in the biomedical field.