Paediatric drug optimization standard procedure

Paediatric drug optimization standard procedure PDF

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 PDF

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 PDF

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.

Delivery of Drugs

Delivery of Drugs PDF

Author: Ranjita Shegokar

Publisher: Elsevier

Published: 2020-02-01

Total Pages: 242

ISBN-13: 0128177772

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Delivery of Drugs: Expectations and Realities of Multifunctional Drug Delivery Systems, Volume Two examines the formulation of micro-nanosized drug delivery systems and recaps opportunities for using physical methods to improve efficacy via mechano-, electroporation. The book highlights innovative delivery methods like PIPAC, including discussions on the regulatory aspects of complex injectables. Written by a diverse range of international researchers from industry and academia, the chapters examine specific aspects of characterization and manufacturing for pharmaceutical applications as well as regulatory and policy aspects. This book connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stakeholders. This level of discussion makes it a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about the status of drug delivery systems. Delivery of Drugs examines the fabrication, optimization, scale-up, biological aspects, regulatory and clinical success of various micro and nano drug delivery systems. The volume covers site and organ specific targeting approaches, technologies used in preparation of micro - nanoparticles, challenges of complex type of drug delivery forms and role of physical methods in achieving targeted drug effect. Written by a diverse range of international researchers the chapters examine the specific aspects of characterization and manufacturing of drug delivery system for pharmaceutical application and its regulatory aspects. 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.

Novel Drug Delivery Technologies

Novel Drug Delivery Technologies PDF

Author: Ambikanandan Misra

Publisher: Springer Nature

Published: 2020-02-12

Total Pages: 448

ISBN-13: 9811336423

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The application of drug delivery is a valuable, cost-effective lifecycle management resource. By endowing drugs with new and innovative therapeutic benefits, drug delivery systems extend products’ profitable lifecycle, giving pharmaceutical companies competitive and financial advantages, and providing patients with improved medications. Formulation development is now being used to create new dosage forms for existing products, which not only reduces the time and expense involved in new drug development, but also helps with regard to patent protection and bypassing existing patents. Today’s culture demands convenience, a major factor determining adherence to drug therapy. Over the past few years, patient convenience-oriented research in the field of drug delivery has yielded a range of innovative drug-delivery options. As a result, various drug-delivery systems, including medicated chewing gums, oral dispersible tablets, medicated lozenges and lollipops, have now hit the market and are very popular. These dosage forms offer a highly convenient way to dose medications, not only for special population groups with swallowing difficulties, such as children and the elderly, but for the general populace as well. This book provides valuable insights into a number of formulation design approaches that are currently being used, or could be used, to provide new benefits from existing drug molecules.

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

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

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 Delivery Systems

Drug Delivery Systems PDF

Author: Vasant V. Ranade

Publisher: CRC Press

Published: 2003-08-26

Total Pages: 464

ISBN-13: 1420040146

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Drug delivery technologies represent a vast and vital area of Research and Development. The demand for innovative drug delivery systems continues to grow, and this growth continues to drive new developments. Building on the foundation provided by the first edition, Drug Delivery Systems, Second Edition covers the latest developments in both

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