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Guide to Paediatric Clinical Research
As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-,...
Pediatric Clinical Pharmacology
The objective of this volume is to give an overview of the present state of the art of pediatric clinical pharmacology including developmental physiology, pediatric-specific pathology, special tools and methods for development of drugs for children (assessment of efficacy, toxicity, long-term safety etc.) as well as regulatory and ethical knowledge and skills. In the future, structural and educational changes have to lead back to a closer cooperation and interaction of pediatrics with (clinical) pharmacology and pharmacy.
Guide to Paediatric Drug Development and Clinical Research
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 un...
Neonatal Pharmacology and Nutrition Update
In order to provide safe and effective drug therapy to neonates, it is necessary to know about and understand the impact their development has on the pharmacokinetics and pharmacodynamics of drugs. The fact that children are different and neonates very different from adults means that, in neonates, it would be unwise to dose medications by scaling down adult doses proportionately, simply attempting to match their smaller weight and/or body surface area. When one makes decisions about neonatal drug therapy, one must not only take into consideration the available data but also critically assess and interpret this information within the context of fetal development and maturational processes as well as within the context of diseases that might affect a drug’s biodisposition. This book includes the latest information on the regulation and scientific basis of drug development and also provides a rationale for formula development for preterm infants. It offers guidance on how to translate pharmacokinetic data into dosing recommendations and also covers legal and regulatory issues relating to neonatal pharmacotherapy.
Rickham's Neonatal Surgery
This book provides a detailed guide to neonatal surgery and its related disciplines including: fetal medicine, fetal surgery, radiology, newborn anaesthesia, intensive care, neonatal medicine, medical genetics, pathology, cardiac surgery, and urology. The book aims to cover all the latest advances in newborn surgery, with contributions from the basic sciences and laboratory research to reflect the steady progress in our current working knowledge and understanding of many neonatal surgical disorders. As huge advances have been made in neonatal surgery in the past decades, ethical issues, long term outcomes, and quality of life are also emphasised. This book is an authoritative reference for surgical residents in training, consultant surgeons, general surgeons with an interest in paediatric surgery, neonatologists, paediatricians, intensive care specialists, and nursing staff.
Model-Based Evaluation of Antimicrobial Agents in Children
Topic Editor Johannes N. van den Anker is the Chief Medical Officer at Reveragen Biopharma, as well as holding his positions at academic institutions. The other Topic Editor declares no competing interests with regard to the Research Topic subject.
Neonatal and Pediatric Clinical Pharmacology, An Issue of Pediatric Clinics - E-Book
The need for safe and effective use of medicines in children and WHO's initiative "Make Medicines Child Size" have boosted research and educational activities in the area of pediatric clinical drug research. This issue focuses on both general and specific aspects of neonatal and pediatric clinical pharmacology including ethics, pharmacogenomics, metabolomics, adverse drug reactions, pain medication, pulmonary hypertension and several other hot topics. The editors have been able to find outstanding authors for the different parts on neonatal and pediatric pharmacology.
Handbook of Toxicology
The Handbook of Toxicology, Third Edition provides an updated practical reference source for practicing toxicologists in the pharmaceutical and chemical industries, contract laboratories, regulatory agencies, and academia. Written by experts in their specific toxicology fields, the chapters provide both fundamental and applied information. Topics r
