Considering the Patient in Pediatric Drug Development Book

Considering the Patient in Pediatric Drug Development


  • Author : Klaus Rose
  • Publisher : Academic Press
  • Release Date : 2020-11-19
  • Genre: Business & Economics
  • Pages : 414
  • ISBN 10 : 9780128242056

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Considering the Patient in Pediatric Drug Development Excerpt :

Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents. Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information

Pediatric Drug Development Book

Pediatric Drug Development


  • Author : Andrew E. Mulberg
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Genre: Medical
  • Pages : 932
  • ISBN 10 : 9781118210437

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Pediatric Drug Development Excerpt :

Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.

Pediatric Drug Development Book

Pediatric Drug Development


  • Author : Andrew E. Mulberg
  • Publisher : Wiley-Blackwell
  • Release Date : 2009-04-13
  • Genre: Medical
  • Pages : 704
  • ISBN 10 : 047016929X

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Pediatric Drug Development Excerpt :

Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.

Pediatric Drug Development Book

Pediatric Drug Development


  • Author : Andrew E. Mulberg
  • Publisher : John Wiley & Sons
  • Release Date : 2013-05-20
  • Genre: Medical
  • Pages : 624
  • ISBN 10 : 9781118312056

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Pediatric Drug Development Excerpt :

Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development.

The COVID 19 Pandemic Book

The COVID 19 Pandemic


  • Author : Klaus Rose
  • Publisher : Academic Press
  • Release Date : 2022-03-14
  • Genre: Science
  • Pages : 248
  • ISBN 10 : 9780323993876

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The COVID 19 Pandemic Excerpt :

The COVID-19 Pandemic: A Global High-Tech Challenge at the Interface of Science, Politics, and Illusions discusses COVID-19 from a historical basis. Many of today’s key decisions are based on flawed assumptions and blind spots, including the belief that healthcare institutions, researchers and authorities are driven by patients’ interests, while industry is greedy. Examples include the US Operation Warp Speed to expedite the development of tools against the pandemic, the EU’s inability to establish a working relationship with vaccine developers, and the success stories of countries such as Israel and Taiwan. This book offers scientists and interested persons orientation and helps to decipher statements from governments and authorities. It will help professionals involved in the approval, planning, implementation and evaluation of COVID-19 studies to distinguish meaningful from pointless. Analyzes key features of the pandemic on the historical background of mankind’s development from hunters and gatherers to modern civilization Opens eyes to the self-interests of institutions and professional associations and resulting conflicts of interest Helps healthcare professionals address critical questions

Drug Discovery and Development Book

Drug Discovery and Development


  • Author : Vishwanath Gaitonde
  • Publisher : BoD – Books on Demand
  • Release Date : 2020-03-11
  • Genre: Medical
  • Pages : 166
  • ISBN 10 : 9781789239751

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Drug Discovery and Development Excerpt :

The process of drug discovery and development is a complex multistage logistics project spanned over 10-15 years with an average budget exceeding 1 billion USD. Starting with target identification and synthesizing anywhere between 10k to 15k synthetic compounds to potentially obtain the final drug that reaches the market involves a complicated maze with multiple inter- and intra-operative fields. Topics described in this book emphasize the progresses in computational applications, pharmacokinetics advances, and molecular modeling developments. In addition the book also contains special topics describing target deorphaning in Mycobacterium tuberculosis, therapy treatment of some rare diseases, and developments in the pediatric drug discovery process.

Pediatric Formulations Book

Pediatric Formulations


  • Author : Daniel Bar-Shalom
  • Publisher : Springer Science & Business Media
  • Release Date : 2014-01-30
  • Genre: Medical
  • Pages : 429
  • ISBN 10 : 9781489980113

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Pediatric Formulations 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.

Addressing the Barriers to Pediatric Drug Development Book

Addressing the Barriers to Pediatric Drug Development


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2008-08-12
  • Genre: Medical
  • Pages : 64
  • ISBN 10 : 0309178657

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Addressing the Barriers to Pediatric Drug Development Excerpt :

Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent--have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

Safe and Effective Medicines for Children Book

Safe and Effective Medicines for Children


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2012-10-13
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780309225496

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Safe and Effective Medicines for Children Excerpt :

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Drug Discovery and Development Book

Drug Discovery and Development


  • Author : Omboon Vallisuta
  • Publisher : BoD – Books on Demand
  • Release Date : 2015-06-03
  • Genre: Medical
  • Pages : 332
  • ISBN 10 : 9789535121282

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Drug Discovery and Development Excerpt :

It is very important for scientists all over the globe to enhance drug discovery research for better human health. This book demonstrates that various expertise are essential for drug discovery including synthetic or natural drugs, clinical pharmacology, receptor identification, drug metabolism, pharmacodynamic and pharmacokinetic research. The following 5 sections cover diverse chapter topics in drug discovery: Natural Products as Sources of Leading Molecules in Drug Discovery; Oncology and Drug Discovery; Receptors Involvement in Drug Discovery; Management and Development of Drugs against Infectious Diseases; Advanced Methodology.

Fundamentals of Pediatric Drug Dosing Book

Fundamentals of Pediatric Drug Dosing


  • Author : Iftekhar Mahmood
  • Publisher : Springer
  • Release Date : 2016-10-28
  • Genre: Medical
  • Pages : 146
  • ISBN 10 : 9783319437545

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Fundamentals of Pediatric Drug Dosing Excerpt :

Focused on pediatric physiology, pharmacology, pharmacokinetics and pharmacodynamics, this book illustrates the differences between the pediatric population and adults; knowledge of extreme importance not only during pediatric drug development but also in the clinical practice. Physicians, nurses, clinical pharmacologists, researchers and healthcare professionals will find this an invaluable resource. With the advent of pediatric exclusivity, and requirements to conduct clinical studies in children, an emphasis has been placed on finding a safe and efficacious dose of a drug in children. Children are not ‘small adults’, and drug dosing in this population requires special consideration. There are subtle physiological and biochemical differences among neonates, infants, children, adolescents and adults and dosing in pediatrics requires proper understanding of these factors. Furthermore, dosing in children, as in adults, should be based on pharmacokinetic and pharmacodynamic data. This is an evolving area, as pediatric pharmacokinetic studies are becoming mandatory for getting approval of new drugs in this population.

Clinical Research in Paediatric Psychopharmacology Book

Clinical Research in Paediatric Psychopharmacology


  • Author : Philippe Auby
  • Publisher : Woodhead Publishing
  • Release Date : 2019-09-15
  • Genre: Medical
  • Pages : 218
  • ISBN 10 : 9780081006177

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Clinical Research in Paediatric Psychopharmacology Excerpt :

Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific and Regulatory Aspects provides a practical guide and overview of the ethical, scientific and regulatory aspects of clinical research in pediatric psychopharmacology, also discussing practical points to consider when developing clinical research in this field. The book is ideal for professionals involved in clinical research in pediatric psychopharmacology, i.e., including, but not limited to pediatricians, health care professionals, researchers, investigators, pharmaceutical company personals and potentially ethics committee members. Topics discussed include the role of patient organization and advocacy groups in research, the role of families and patients: ‘should I involve my kid in clinical research, and historical, ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology. Covers both theoretical and practical aspects of clinical research in paediatric psychopharmacology Approaches the topic from different angles from the regulatory framework to the patient perspective Discusses ethical and safety considerations for research in paediatric psychopharmacology Offers future perspective for paediatric development

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition


  • Author : Allen Cato
  • Publisher : CRC Press
  • Release Date : 2002-03-26
  • Genre: Medical
  • Pages : 451
  • ISBN 10 : 9780824744809

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Clinical Drug Trials and Tribulations Revised and Expanded Second Edition Excerpt :

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book

A Comprehensive Guide to Toxicology in Preclinical Drug Development


  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2012-10-18
  • Genre: Medical
  • Pages : 1024
  • ISBN 10 : 9780123878168

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A Comprehensive Guide to Toxicology in Preclinical Drug Development Excerpt :

A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source