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| 003 - IDENTIFICADOR DEL NÚMERO DE CONTROL |
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ES-MaUEC |
| 005 - FECHA Y HORA DE LA ÚLTIMA TRANSACCIÓN |
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| 008 - DATOS DE LONGITUD FIJA--INFORMACIÓN GENERAL |
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140130s2014 xxua s 001 0 eng d |
| 020 ## - NÚMERO INTERNACIONAL ESTÁNDAR DEL LIBRO |
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| Número Internacional Estándar del Libro |
9781489980113 |
| 024 7# - IDENTIFICADOR DE OTROS ESTÁNDARES |
|---|
| Número estándar o código |
10.1007/978-1-4899-8011-3 |
| Fuente del número o código |
doi |
| 050 #4 - SIGNATURA TOPOGRÁFICA DE LA BIBLIOTECA DEL CONGRESO |
|---|
| Número de clasificación |
RJ560 |
| Número de documento/Ítem |
.B377 2014 |
| 082 04 - NÚMERO DE LA CLASIFICACIÓN DECIMAL DEWEY |
|---|
| Número de clasificación |
615.19 |
| 245 00 - MENCIÓN DE TÍTULO |
|---|
| Título |
Pediatric Formulations : |
| Resto del título |
A Roadmap |
| Mención de responsabilidad, etc. |
edited by Daniel Bar-Shalom, Klaus Rose |
| 264 #1 - PRODUCCIÓN, PUBLICACIÓN, DISTRIBUCIÓN, FABRICACIÓN Y COPYRIGHT |
|---|
| Producción, publicación, distribución, fabricación y copyright |
New York, NY |
| Nombre del de productor, editor, distribuidor, fabricante |
Springer New York |
| Fecha de producción, publicación, distribución, fabricación o copyright |
2014 |
| 300 ## - DESCRIPCIÓN FÍSICA |
|---|
| Extensión |
1 recurso en línea (XV, 439 páginas) |
| Otras características físicas |
76 ilustraciones, 36 ilustraciones en color |
| 336 ## - TIPO DE CONTENIDO |
|---|
| Término de tipo de contenido |
Texto (visual) |
| Código de tipo de contenido |
txt |
| Fuente |
rdacontent |
| 337 ## - TIPO DE MEDIO |
|---|
| Nombre/término del tipo de medio |
electrónico |
| Código del tipo de medio |
c |
| Fuente |
rdamedia |
| 338 ## - TIPO DE SOPORTE |
|---|
| Nombre/término del tipo de soporte |
recurso electrónico |
| Código del tipo de soporte |
cr |
| Fuente |
rdacarrier |
| 490 1# - MENCIÓN DE SERIE |
|---|
| Mención de serie |
AAPS Advances in the Pharmaceutical Sciences Series |
| Número Internacional Normalizado para Publicaciones Seriadas |
2210-7371 |
| Designación de volumen o secuencia |
11 |
| 505 0# - NOTA DE CONTENIDO CON FORMATO |
|---|
| Nota de contenido con formato |
Pediatric Development: Anatomy -- Age, Weight, Body Surface and Stature, Organ Development -- Pediatric Development: Physiology. Enzymes, Drug Metabolism, Pharmacokinetics and Pharmacodynamics -- Pediatric Development â€{u01E1}strointestinal -- How to Estimate the Dose to be Given for the First Time to Pediatric Patients -- The Clinical Relevance of Pediatric Formulations -- General Considerations for Pediatric Oral Drug Formulation -- Orosensory Perception -- Flavor Is Not Just Taste: Taste Concealing -- Liquid Formulations -- Paediatric Solid Formulations -- Semi-Solid Formulations -- The Challenge of Automated Compounding -- Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation -- Buccal/Sublingual Drug Delivery for the Paediatric Population -- Topical and Transdermal -- Parenteral Liquids for Intravenous and Transdermal Use -- The Challenges of Paediatric Pulmonary Drug Delivery -- Nasal, Ocular and Otic Drug Delivery -- Rectal Drug Delivery -- Intraosseous Infusions in Infants and Neonates -- Compounding for Children â€{u0528}e Compounding Pharmacist -- Food Ingredients -- Excipients and Active Pharmaceutical Ingredients (APIs) -- Clinical Testing in Children -- Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the United States and Implementation of Quality by Design -- Pediatric Pharmaceutical Legislation and its impact on Adult and Pediatric Drug Development: The EU Regulatory View -- Pediatric Pharmaceutical Legislation in USA and EU and their impact on Adult and Pediatric Drug Development -- Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation -- The Dangerous Business Of Predicting The Future. |
| 520 3# - SUMARIO, ETC. |
|---|
| Sumario, etc. |
As the first book that specifically addresses pediatric formulations in the context of drug development, Pediatric Formulations: A Roadmap covers anatomy and physiology of children as well as the technical state of the art, gives hints about where to find inspiration, and provides a suitable background on the regulatory framework. Existing books on pediatric formulations mainly discuss compounding at the pharmacy. This is not a “how to formulateâ€{u0D25}xtbook for pharmaceutical scientists; the subtitle “A Roadmapâ€{u0A6E}dicates that we are on a path in largely unexplored territory. It is an attempt to equip the reader with necessary information on how to get started with the appropriate mindset. Among medicinal specialties, pediatrics is a young discipline. The potential dangers of medicine were often underestimated in earlier times. Cough suppressants labeled as “suitable for children and adultsâ€{u0860}hundred years ago could kill children as they contained opioids. Since then, a complex framework has evolved, with physicians, pharmacists, drug development companies, generic companies, academic scientists, regulatory authorities, reimbursement organizations, patients and childrenâ€{u3830}arents as key players. The position of children in our society has changed dramatically during the last century. Children were protected against clinical trials, yet thanks to clinical trials, many more children with cancer survive today. The development of age-adjusted drug formulations is not only a technical challenge. For new drugs today, there are laws both in the United States and the European Union that compel the research-based pharmaceutical industry to also consider children during drug development. One of the major demands of authorities is the development of age-appropriate formulations. Daniel Bar-Shalom is an Associate Professor in Drug Delivery at The Faculty of Health and Medical Sciences, University of Copenhagen. He has a degree in Biology from The Tel-Aviv University (1975), carried research in botany and then graduated from the School of Pharmacy, Hebrew University of Jerusalem (1982). He is a qualified pharmacist and has managed and owned a pharmacy in Haifa where he gained insight into the needs and idiosyncrasies of patients. He moved to Denmark in 1986 and founded Egalet, a drug delivery company where he served until 2007 as Vice President, R&D. He has been a consultant for various pharmaceutical and medical device companies. He is also the inventor of various technologies, holds many patents and has formulated marketed products. His main interests are controlled drug delivery and in particular oral pediatric formulations and geriatric formulations addressing the problem of polypharmacy. Dr. Klaus Rose is CEO of Klausrose Consulting, Switzerland and advises on pediatric drug development and how to comply with FDA and EMA pediatric requirements. He has studied Latin languages, psychology and medicine. After postgraduate clinical training in general medicine in Germany and England, he joined the pharmaceutical industry. He has held various positions in R&D and medical affairs, was Global Head Pediatrics Novartis from 2001 to 2005 and was Global Head Pediatrics Roche from 2005 to 2009. After a year with a regulatory consultancy, he established his own business. Dr. Rose is a frequent speaker on international conferences on pediatric drug development, organizes trainings and publishes on a regular base. |
| 650 #7 - PUNTO DE ACCESO ADICIONAL DE MATERIA--TÉRMINO DE MATERIA |
|---|
| Término de materia o nombre geográfico como elemento de entrada |
Tecnología farmacéutica |
| Número de control del registro de autoridad o número normalizado |
LocalV |
| Fuente del encabezamiento o término |
embne |
| 9 (RLIN) |
161127 |
| 650 #7 - PUNTO DE ACCESO ADICIONAL DE MATERIA--TÉRMINO DE MATERIA |
|---|
| Término de materia o nombre geográfico como elemento de entrada |
Farmacia |
| Número de control del registro de autoridad o número normalizado |
LocalV |
| Fuente del encabezamiento o término |
embne |
| 9 (RLIN) |
137891 |
| 710 2# - PUNTO DE ACCESO ADICIONAL--NOMBRE DE ENTIDAD CORPORATIVA |
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| Nombre de entidad corporativa o nombre de jurisdicción como elemento de entrada |
SpringerLink (Online service) |
| Número de control del registro de autoridad o número normalizado |
Local |
| 9 (RLIN) |
106996 |
| 700 1# - PUNTO DE ACCESO ADICIONAL--NOMBRE DE PERSONA |
|---|
| Nombre de persona |
Bar-Shalom, Daniel |
| Término indicativo de función/relación |
editor. |
| Número de control del registro de autoridad o número normalizado |
Local |
| 9 (RLIN) |
84979 |
| 700 1# - PUNTO DE ACCESO ADICIONAL--NOMBRE DE PERSONA |
|---|
| Nombre de persona |
Rose, Klaus |
| Término indicativo de función/relación |
editor literario |
| 9 (RLIN) |
84980 |
| Número de control del registro de autoridad o número normalizado |
Local |
| 856 40 - LOCALIZACIÓN Y ACCESO ELECTRÓNICOS |
|---|
| Identificador Uniforme del Recurso |
https://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4899-8011-3 |
| Nota pública |
Acceso a este recurso digital (usuarios Universidad Europea de Madrid) |
| 942 ## - ELEMENTOS DE PUNTO DE ACCESO ADICIONAL (KOHA) |
|---|
| Fuente del sistema de clasificación o colocación |
Library of Congress Classification |
| Tipo de ítem Koha |
LIBRO-E NO PRÉSTAMO |
| 988 ## - NOTA LOCAL 598 |
|---|
| Nota local 598 |
EBSPRINGER |
| 901 ## - ID MILLENIUM |
|---|
| Id Millenium |
i9781489980113 |
| 907 ## - TRANSACCIONES MILLENIUM |
|---|
| id bib interno millenium |
.b12817223 |
| fecha actualizac reg bib |
10-10-17 |
| fecha creacion reg bib |
01-10-14 |
| 998 ## - FONDO MILLENIUM |
|---|
| Biblioteca |
m |
| -- |
_alco |
| -- |
_vill |
| Fecha creación |
29-09-17 |
| Tipo de registro |
m |
| Tipo de materia |
E-book |
| e |
a |
| Idioma |
eng |
| País |
xxu |
| h |
0 |
| 945 ## - ITEM MILLENIUM |
|---|
| Signatura |
RJ560 .B377 2014 EB |
| Número de copia |
1 |
| Código de barras |
eBOOK |
| Agencia |
0 |
| Localización del ejemplar (ubicación) |
mae |
| Código 2 (categoría) |
- |
| Precio |
EUR0.00 |
| Mensaje (popup en cliente staff) |
- |
| Mensaje (visible en OPAC) |
- |
| Estado |
b |
| Tipo de ejemplar |
15 |
| Total de préstamos |
0 |
| Total de renovaciones |
0 |
| Préstamos del año en curso |
0 |
| Préstamos del año anterior |
0 |
| Identificador de la copia de ejemplar en Millennium |
.i1154644x |
| Fecha de creación del ejemplar |
06-04-17 |
| 999 ## - NÚMEROS DE CONTROL DE SISTEMA (KOHA) |
|---|
| -- |
1 |