Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.

Download or read book Excipient Applications in Formulation Design and Drug Delivery written by Ajit S Narang and published by Springer. This book was released on 2015-10-07 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Download or read book Compounded Topical Pain Creams written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-07-21 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2024-04-26 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. The Expert Committee develops standards through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use: WHO good manufacturing practices for excipients used in pharmaceutical products (revision); IAEA/WHO good manufacturing practices for in-house cold kits for radiopharmaceutical preparations (new); WHO good practices for pharmaceutical quality control laboratories (revision); WHO/UNFPA female condom generic specification (new); WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release (updated), solid oral dosage forms; WHO guideline on Biopharmaceutics Classification System-based biowaivers (revision); and Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (republished). All of the above are included in this report and recommended for implementation.

Download or read book Hot Melt Extrusion written by Dennis Douroumis and published by John Wiley & Sons. This book was released on 2012-04-24 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hot-melt extrusion (HME) - melting a substance and forcing it through an orifice under controlled conditions to form a new material - is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.

Download or read book Nanopharmaceuticals Principles and Applications Vol 3 written by Vinod Kumar Yata and published by Springer Nature. This book was released on 2020-08-19 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the third volume on this subject and focuses on the recent advances of nanopharmaceuticals in cancer, dental, dermal and drug delivery applications and presents their safety, toxicity and therapeutic efficacy. The book also includes the transport phenomenon of nanomaterials and important pathways for drug delivery applications. It goes on to explain the toxicity of nanoparticles to different physiological systems and methods used to assess this for different organ systems using examples of in vivo systems.

Download or read book Mechanochemistry in Nanoscience and Minerals Engineering written by Peter Balaz and published by Springer Science & Business Media. This book was released on 2008-10-20 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mechanochemistry as a branch of solid state chemistry enquires into processes which proceed in solids due to the application of mechanical energy. This provides a thorough, up to date overview of mechanochemistry of solids and minerals. Applications of mechanochemistry in nanoscience with special impact on nanogeoscience are described. Selected advanced identification methods, most frequently applied in nanoscience, are described as well as the advantage of mechanochemical approach in minerals engineering. Examples of industrial applications are given. Mechanochemical technology is being applied in many industrial fields: powder metallurgy (synthesis of nanometals, alloys and nanocompounds), building industry (activation of cements), chemical industry (solid waste treatment, catalyst synthesis, coal ashes utilization), minerals engineering (ore enrichment, enhancement of processes of extractive metallurgy), agriculture industry (solubility increase of fertilizers), and pharmaceutical industry (improvement of solubility and bioavailability of drugs). This reference serves as an introduction to newcomers to mechanochemistry, and encourages more experienced researchers to broaden their knowledge and discover novel applications in the field.

Download or read book Oral Mucosal Drug Delivery and Therapy written by Michael J. Rathbone and published by Springer. This book was released on 2015-03-13 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides a comprehensive overview of the current issues facing scientists working on delivering drugs locally and systemically via the membranes that line the mouth. The book describes the anatomical and physiological challenges of this route for drug delivery and how they impact the design of oral mucosal drug delivery systems. It also provides a detailed description of current oral mucosal drug delivery technologies that overcome these challenges alongside research, development and assessment methods. In 11 authoritative chapters, the book affords an in-depth evaluation of the major issues associated with this route of administration, namely the retention of the drug/product at the site of administration and increasing drug permeability through the oral mucosa. The book provides insights into the in vitro and in vivo methods available to assess drug permeability and retention, offers solutions on how to improve the permeation of the drugs through the oral mucosa, and explores approaches to prolong drug/product retention at the site of administration. It also indicates future directions in research and product development. Oral Mucosal Drug Delivery and Therapy is a key resource for those wishing to extend their knowledge of this field.

Download or read book Pharmacokinetics of Drugs written by Peter G. Welling and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt: A compilation of researchers' experience in the areas of bioanalysis, pharmacokinetics, and drug metabolism, to present an up-to-date and comprehensive treatise on the application of these and related technologies in drug discovery, development, and clinical use. Contents cover descriptions of analytical methods, in vitro metabolism technology and membrane transport, reappraisal of classical pharmacokinetic problems, and the time course of drug action. The book concludes with a description of PET and imaging methods in pharmacokinetics and an appendix containing a critical appraisal of computer methods and pharmacokinetic software available for PCs.

Download or read book Biopharmaceutics Applications in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2007-09-20 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

Download or read book Recent Development of Electrospinning for Drug Delivery written by Romána Zelkó and published by MDPI. This book was released on 2020-03-27 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: Several promising techniques have been developed to overcome the poor solubility and/or membrane permeability properties of new drug candidates, including different fiber formation methods. Electrospinning is one of the most commonly used spinning techniques for fiber formation, induced by the high voltage applied to the drug-loaded solution. With modifying the characteristics of the solution and the spinning parameters, the functionality-related properties of the formulated fibers can be finely tuned. The fiber properties (i.e., high specific surface area, porosity, and the possibility of controlling the crystalline–amorphous phase transitions of the loaded drugs) enable the improved rate and extent of solubility, causing a rapid onset of absorption. However, the enhanced molecular mobility of the amorphous drugs embedded into the fibers is also responsible for their physical–chemical instability. This Special Issue will address new developments in the area of electrospun nanofibers for drug delivery and wound healing applications, covering recent advantages and future directions in electrospun fiber formulations and scalability. Moreover, it serves to highlight and capture the contemporary progress in electrospinning techniques, with particular attention to the industrial feasibility of developing pharmaceutical dosage forms. All aspects of small molecule or biologics-loaded fibrous dosage forms, focusing on the processability, structures and functions, and stability issues, are included.

Download or read book Biopharmaceutics Modeling and Simulations written by Kiyohiko Sugano and published by John Wiley & Sons. This book was released on 2012-07-31 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive introduction to using modeling and simulation programs in drug discovery and development Biopharmaceutical modeling has become integral to the design and development of new drugs. Influencing key aspects of the development process, including drug substance design, formulation design, and toxicological exposure assessment, biopharmaceutical modeling is now seen as the linchpin to a drug's future success. And while there are a number of commercially available software programs for drug modeling, there has not been a single resource guiding pharmaceutical professionals to the actual tools and practices needed to design and test safe drugs. A guide to the basics of modeling and simulation programs, Biopharmaceutics Modeling and Simulations offers pharmaceutical scientists the keys to understanding how they work and are applied in creating drugs with desired medicinal properties. Beginning with a focus on the oral absorption of drugs, the book discusses: The central dogma of oral drug absorption (the interplay of dissolution, solubility, and permeability of a drug), which forms the basis of the biopharmaceutical classification system (BCS) The concept of drug concentration How to simulate key drug absorption processes The physiological and drug property data used for biopharmaceutical modeling Reliable practices for reporting results With over 200 figures and illustrations and a peerless examination of all the key aspects of drug research—including running and interpreting models, validation, and compound and formulation selection—this reference seamlessly brings together the proven practical approaches essential to developing the safe and effective medicines of tomorrow.

Download or read book Processes and Phenomena on the Boundary Between Biogenic and Abiogenic Nature written by Olga V. Frank-Kamenetskaya and published by Springer Nature. This book was released on 2019-08-29 with total page 900 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book represents a collection of papers presented at VI International Symposium "Biogenic - abiogenic interactions in natural and anthropogenic systems" that was held on 24-27 September 2018 in Saint Petersburg (Russia). Papers in this book cover a wide range of topics connecting with interactions between biogenic and abiogenic components in lithosphere, biosphere and technosphere. The main regarding topics are following: methods for studying the interactions between biogenic and abiogenic components; geochemistry of biogenic-abiogenic systems; biomineralization and nature-like materials and technologies; medical geology; biomineralogy and organic mineralogy; biomineral interactions in soil; biodeterioration of natural and artificial materials; biomineral interactions in extreme environment.

Download or read book Biomedical Science and Technology written by A. Atilla Hincal and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advancing with Biomedical Engineering Today, in most developed countries, modem hospitals have become centers of sophis ticated health care delivery using advanced technological methods. These have come from the emergence of a new interdisciplinary field and profession, commonly referred to as "Bio medical Engineering." Although what is included in the field of biomedical engineering is quite clear, there are some disagreements about its definition. In its most comprehensive meaning, biomedical engineering is the application of the principles and methods of engi neering and basic sciences to the understanding of the structure-function relationships in normal and pathological mammalian tissues, as well as the design and manufacture of prod ucts to maintain, restore, or improve tissue functions, thus assisting in the diagnosis and treat ment of patients. In this very broad definition, the field of biomedical engineering now includes: • System analysis (modeling, simulation, and control of the biological system) • Biomedical instrumentation (detection, measurement, and monitoring of physio logic signals) • Medical imaging (display of anatomic details or physiologic functions for diag nosis) • Biomaterials (development of materials used in prostheses or in medical devices) • Artificial organs (design and manufacture of devices for replacement or augmen tation of tissues or organs) • Rehabilitation (development oftherapeutic and rehabilitation procedures and de vices) • Diagnostics (development of expert systems for diagnosis of diseases) • Controlled drug delivery (development of systems for administration of drugs and other active agents in a controlled manner, preferably to the target area)

Download or read book Long Acting Injections and Implants written by Jeremy C. Wright and published by Springer Science & Business Media. This book was released on 2012-01-29 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Long acting injections and implants improve therapy, enhance patient compliance, improve dosing convenience, and are the most appropriate formulation choice for drugs that undergo extensive first pass metabolism or that exhibit poor oral bioavailability. An intriguing variety of technologies have been developed to provide long acting injections and implants. Many considerations need to go into the design of these systems in order to translate a concept from the lab bench to actual therapy for a patient. This book surveys and summarizes the field. Topics covered in Long Acting Injections and Implants include the historical development of the field, drugs, diseases and clinical applications for long acting injections and implants, anatomy and physiology for these systems, specific injectable technologies (including lipophilic solutions, aqueous suspensions, microspheres, liposomes, in situ forming depots and self-assembling lipid formulations), specific implantable technologies (including osmotic implants, drug eluting stents and microfabricated systems), peptide, protein and vaccine delivery, sterilization, drug release testing and regulatory aspects of long acting injections and implants. This volume provides essential information for experienced development professionals but was also written to be useful for scientists just beginning work in the field and for others who need an understanding of long acting injections and implants. This book will also be ideal as a graduate textbook.

Download or read book 5th International Conference on Biomedical Engineering in Vietnam written by Vo Van Toi and published by Springer. This book was released on 2014-11-18 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume presents the proceedings of the Fifth International Conference on the Development of Biomedical Engineering in Vietnam which was held from June 16-18, 2014 in Ho Chi Minh City. The volume reflects the progress of Biomedical Engineering and discusses problems and solutions. I aims identifying new challenges, and shaping future directions for research in biomedical engineering fields including medical instrumentation, bioinformatics, biomechanics, medical imaging, drug delivery therapy, regenerative medicine and entrepreneurship in medical devices.

Download or read book The Selection and Use of Essential Medicines written by WHO Expert Committee on the Selection and Use of Essential Medicines and published by Diamond Pocket Books (P) Ltd.. This book was released on 2004 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.