Paediatric Formulation
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Paediatric Formulation
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Author : Nunzio Denora
language : en
Publisher: MDPI
Release Date : 2021-09-02
Paediatric Formulation written by Nunzio Denora and has been published by MDPI this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-02 with Science categories.
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.
Pediatric Formulations
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Author : Daniel Bar-Shalom
language : en
Publisher: Springer Science & Business Media
Release Date : 2014-01-30
Pediatric Formulations written by Daniel Bar-Shalom and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-01-30 with Medical categories.
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.
Guide To Paediatric Drug Development And Clinical Research
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Author : Klaus Rose
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2010-01-01
Guide To Paediatric Drug Development And Clinical Research written by Klaus Rose and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-01-01 with Medical categories.
Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects.A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
Pharmaceutical Formulation
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Author : Geoffrey D Tovey
language : en
Publisher: Royal Society of Chemistry
Release Date : 2018-06-25
Pharmaceutical Formulation written by Geoffrey D Tovey and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-25 with Science categories.
Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.
Shaping The Global Innovation And Access Landscape For Better Paediatric Medicines
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2022-03-25
Shaping The Global Innovation And Access Landscape For Better Paediatric Medicines written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-03-25 with Medical categories.
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.
Essentials Of Translational Pediatric Drug Development
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Author : Elke Gasthuys
language : en
Publisher: Elsevier
Release Date : 2024-07-23
Essentials Of Translational Pediatric Drug Development written by Elke Gasthuys and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-23 with Medical categories.
Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development
Paediatric Drug Handling
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Author : Ian Costello
language : en
Publisher: Pharmaceutical Press
Release Date : 2007
Paediatric Drug Handling written by Ian Costello and has been published by Pharmaceutical Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Medical categories.
This book provides a comprehensive overview of all of the issues pharmacists serving pediatric patients must consider. Chapters relating to pharmacogenomics, medication error prevention, compounding, and government regulations are extremely informative.
Paediatric Clinical Pharmacology
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Author : Evelyne Jacqz-Aigrain
language : en
Publisher: CRC Press
Release Date : 2021-02-25
Paediatric Clinical Pharmacology written by Evelyne Jacqz-Aigrain and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-02-25 with Medical categories.
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.
Paediatric Drug Optimization For Tuberculosis
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-05-30
Paediatric Drug Optimization For Tuberculosis written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-05-30 with Medical categories.
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.
Drug Development
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Author : Chris Rundfeldt
language : en
Publisher: BoD – Books on Demand
Release Date : 2011-12-07
Drug Development written by Chris Rundfeldt and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-07 with Medical categories.
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.