Paediatric drug optimization standard procedure
Paediatric drug optimization standard procedure

Author:

Publisher: World Health Organization

Published: 2021-11-19

Total Pages: 24

ISBN-13: 924003952X

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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.

Paediatric drug optimization for tuberculosis
Paediatric drug optimization for tuberculosis

Author: World Health Organization

Publisher: World Health Organization

Published: 2024-05-30

Total Pages: 56

ISBN-13: 9240094822

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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.

3D Printing of Pharmaceutical and Drug Delivery Devices
3D Printing of Pharmaceutical and Drug Delivery Devices

Author: Dimitrios A. Lamprou

Publisher: John Wiley & Sons

Published: 2024-05-15

Total Pages: 276

ISBN-13: 1119835984

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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.

Monoclonal antibodies for malaria prevention: preferred product characteristics and clinical development considerations
Monoclonal antibodies for malaria prevention: preferred product characteristics and clinical development considerations

Author: World Health Organization

Publisher: World Health Organization

Published: 2023-04-20

Total Pages: 36

ISBN-13: 9240070982

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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.

Drug Development
Drug Development

Author: Chris Rundfeldt

Publisher: BoD – Books on Demand

Published: 2011-12-07

Total Pages: 657

ISBN-13: 9533072571

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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.

Oral Drug Absorption
Oral Drug Absorption

Author: Jennifer B. Dressman

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 432

ISBN-13: 1420077341

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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

Pediatric Formulations
Pediatric Formulations

Author: Daniel Bar-Shalom

Publisher: Springer Science & Business Media

Published: 2014-01-30

Total Pages: 429

ISBN-13: 1489980113

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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.

Drug Delivery Trends
Drug Delivery Trends

Author: Ranjita Shegokar

Publisher: Elsevier

Published: 2020-03-01

Total Pages: 248

ISBN-13: 012817871X

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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