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008			140130s2014 xxua s 001 0 eng d
020			_a9781489980113
024	7		_a10.1007/978-1-4899-8011-3 _2doi
050		4	_aRJ560 _b.B377 2014
082	0	4	_a615.19
245	0	0	_aPediatric Formulations : _bA Roadmap _cedited by Daniel Bar-Shalom, Klaus Rose
264		1	_aNew York, NY _bSpringer New York _c2014
300			_a1 recurso en línea (XV, 439 páginas) _b76 ilustraciones, 36 ilustraciones en color
336			_aTexto (visual) _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490	1		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v11
505	0		_aPediatric 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		_aAs 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.
710	2		_aSpringerLink (Online service) _0Local _9106996
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988			_aEBSPRINGER
650		7	_aTecnología farmacéutica _0LocalV _2embne _9161127
650		7	_aFarmacia _0LocalV _2embne _9137891
700	1		_aBar-Shalom, Daniel _eeditor. _0Local _984979
700	1		_aRose, Klaus _eeditor literario _984980 _0Local
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4899-8011-3 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
901			_ai9781489980113
907			_a.b12817223 _b10-10-17 _c01-10-14
998			_am _a_alco _a_vill _b29-09-17 _cm _dz _ea _feng _gxxu _h0
945			_aRJ560 .B377 2014 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i1154644x _z06-04-17
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