Download or read book Innovative delivery systems for paediatric medicines written by and published by World Health Organization. This book was released on 2021-11-10 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Paediatric drug optimization standard procedure written by and published by World Health Organization. This book was released on 2021-11-19 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this document is to provide guidance on how to undertake a paediatric drug optimization (PADO) exercise and identify key priority products for research and development. This guidance is for all technical units undertaking a PADO exercise, all stakeholders involved in PADO processes as well as interested organizations and experts involved in the research and development of therapeutics in the public and private sectors.
Download or read book Paediatric drug optimization for tuberculosis written by World Health Organization and published by World Health Organization. This book was released on 2024-05-30 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Paediatric drug optimization (PADO) exercises have been convened by the World Health Organization (WHO) for various diseases, demonstrating their potential and impact to accelerate access to optimal formulations in the context of fragmented small markets for medicines for children. The WHO Global Tuberculosis Programme has convened PADO-TB meetings since February 2019 (PADO-TB1), followed by an interim review of the PADO-TB1 priorities in September 2020. Optimization of paediatric TB medicines forms part of the key actions in the Roadmap towards ending TB in children and adolescents, third edition and contributes to the achievement of the targets for ending TB in children and adolescents set out at the second United Nations High-level Meeting on the Fight Against TB in 2023. Considering the latest WHO recommendations on drug-susceptible TB, drug-resistant TB and TB preventive treatment, recent developments in new TB medicines and formulations made available, results of clinical trials and studies, and advancements of key medicines in the TB R&D pipeline, WHO convened the second PADO-TB meeting (PADO-TB2) on 3–5 October 2023. This meeting report summarizes the proceedings, discussions and the main consensus-based outputs of the PADO-TB2 meeting: - PADO-TB2 priority list (priority formulations to be investigated/developed in the short term and essential formulations to be developed in the longer term) - PADO-TB2 watch list (promising candidates for investigation/development for children within 5–10 years) - Priority research questions.
Download or read book 3D Printing of Pharmaceutical and Drug Delivery Devices written by Dimitrios A. Lamprou and published by John Wiley & Sons. This book was released on 2024-05-15 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D Printing of Pharmaceutical and Drug Delivery Devices 3D Printing of Pharmaceutical and Drug Delivery Devices Discover the latest, fast-developing technology to help move towards more cost-effective, small-batch, decentralized manufacturing of personalized systems 3D printing has revolutionized manufacturing. Its precision and flexibility have enabled the large-scale production of materials and devices too complex for conventional industrial manufacturing. This has been particularly revolutionary in the field of pharmaceutical production, where 3D printing is being integrated into the manufacture of both drugs and drug delivery devices. It has never been more important for industry professionals to understand this form of production. 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside offers a comprehensive overview of 3D printing technology and its pharmaceutical applications. It introduces readers to a world in which bespoke drug delivery systems developed for specific users or conditions is rapidly becoming a reality. Its detailed coverage of strategies and industrial processes incorporates the latest research and real-world experience of production. 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside readers will also find: A multi-disciplinary authorial team of industry leaders Discussion of common technical and regulatory barriers and their possible solutions Far-ranging discussion of pharmaceutical applications across all sectors 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside is essential reading for pharmaceutical industry professionals and researchers looking to occupy the leading edge.
Download or read book Monoclonal antibodies for malaria prevention preferred product characteristics and clinical development considerations written by World Health Organization and published by World Health Organization. This book was released on 2023-04-20 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preferred product characteristics (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for monoclonal antibodies (mAbs) for malaria prevention. Alongside the development of new malaria vaccines and chemoprevention drugs, there have been recent R&D advances in the development of mAbs for malaria prevention. Passive immunization with mAbs through direct administration of functional antibodies could potentially overcome some of the limitations of vaccines by providing immediate protection. Furthermore, mAbs with simplified dose regimens could potentially circumvent some of the coverage and adherence issues faced by malaria chemoprevention. To support this quickly developing R&D area, WHO convened a scientific development group to consider the PPCs for mAbs to be used for malaria prevention, with a focus on the reduction of morbidity and mortality in infants and children due to Plasmodium falciparum.
Download or read book Shaping the global innovation and access landscape for better paediatric medicines written by World Health Organization and published by World Health Organization. This book was released on 2022-03-25 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAP-f’s three-year strategic plan (2022-2024) builds from the work undertaken to date by the network of leading partners, both individually and collectively, through GAP-f. With this strategy, GAP-f is excited to increase its footprint into a broader set of diseases to bring it closer to its vision of all children having equitable access to the medicines they need.
Download or read book Shaping the global innovation and access landscape for better paediatric medicines written by World Health Organization and published by World Health Organization. This book was released on 2022-08-26 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Development written by Chris Rundfeldt and published by BoD – Books on Demand. This book was released on 2011-12-07 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents a case study based overview of many different aspects of drug development, ranging from target identification and characterization to chemical optimization for efficacy and safety, as well as bioproduction of natural products utilizing for example lichen. In the last section, special aspects of the formal drug development process are discussed. Since drug development is a highly complex multidisciplinary process, case studies are an excellent tool to obtain insight in this field. While each chapter gives specific insight and may be read as an independent source of information, the whole book represents a unique collection of different facets giving insight in the complexity of drug development.
Download or read book Oral Drug Absorption written by Jennifer B. Dressman and published by CRC Press. This book was released on 2016-04-19 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an
Download or read book Pediatric Formulations written by Daniel Bar-Shalom and published by Springer Science & Business Media. This book was released on 2014-01-30 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.
Download or read book Promoting Safety of Medicines for Children written by World Health Organization and published by World Health Organization. This book was released on 2007 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.
Download or read book Drug Delivery Trends written by Ranjita Shegokar and published by Elsevier. This book was released on 2020-03-01 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Delivery Trends examines a drift in the pharmaceutical field across the wide range of dosage forms, drug delivery systems (micro and nanoparticulate), at the regulatory front and on new types of therapies in the market. This volume additionally covers the challenges on drug delivery systems in terms of preclinical and current ways of determining quality and the options to solve the challenges associated with this. Most small-medium scale industries and academics struggle with initial regulatory challenges so a detailed discussion on regulatory trend covers the necessary basic understanding of regulatory procedures and provides the required guidance. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems. Encompasses trends in drug delivery systems and selected dosage forms Illustrates regulatory, preclinical and quality principles Contains in-depth investigation of upcoming types of drug delivery systems
Download or read book An Introduction to Clinical Pharmaceutics written by Alexander Taylor Florence and published by Pharmaceutical Press. This book was released on 2010 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook describes a variety of dosage forms and their clinical importance and use. The use and behaviour of dosage forms in different age groups and patient groups will also be considered along with recent developments such as personalised therapies and genomics. It contains relevant examples and clinical case studies.
Download or read book Paediatric Formulation written by Nunzio Denora and published by MDPI. This book was released on 2021-09-02 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development of paediatric medicines can be challenging since this is a different patient population with specific needs. A medicine designed for use in paediatric patients must consider the following aspects: patient population variability; the need for dose flexibility; route of administration; patient compliance; excipient tolerability. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Globally, about 75% of drugs do not carry regulatory approval for use in children; worldwide, many medications prescribed for the treatment of paediatric diseases are used off-label, and less than 20% of package inserts have sufficient information for treating children. This book provides an update on both state-of-the-art methodology and operational challenges in paediatric formulation design and development. It aims at re-evaluating what is needed for more progress in the design and development of age-appropriate treatments for paediatric diseases, focusing on: formulation development; drug delivery design; efficacy, safety, and tolerability of drugs and excipients.
Download or read book Technical Report Series written by and published by . This book was released on 2009 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Paediatric Clinical Pharmacology written by Evelyne Jacqz-Aigrain and published by CRC Press. This book was released on 2021-02-25 with total page 830 pages. Available in PDF, EPUB and Kindle. Book excerpt: The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals effectively treat children with the most appropriate medicine with minimal side effects.
Download or read book 3D Printing of Pharmaceuticals and Drug Delivery Devices written by Dimitrios A. Lamprou and published by MDPI. This book was released on 2020-07-01 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 3D printing (3DP) process was patented in 1986; however, only in the last decade has it begun to be used for medical applications, as well as in the fields of prosthetics, bio-fabrication, and pharmaceutical printing. 3DP or additive manufacturing (AM) is a family of technologies that implement layer-by-layer processes in order to fabricate physical models based on a computer aided design (CAD) model. 3D printing permits the fabrication of high degrees of complexity with great reproducibility in a fast and cost-effective fashion. 3DP technology offers a new paradigm for the direct manufacture of individual dosage forms and has the potential to allow for variations in size and geometry as well as control dose and release behavior. Furthermore, the low cost and ease of use of 3DP systems means that the possibility of manufacturing medicines and medical devices at the point of dispensing or at the point of use could become a reality. 3DP thus offers the perfect innovative manufacturing route to address the critical capability gap that hinders the widespread exploitation of personalized medicines for molecules that are currently not easy to deliver. This Special Issue will address new developments in the area of 3D printing and bioprinting for drug delivery applications, covering the recent advantages and future directions of additive manufacturing for pharmaceutical products.
