Verfügbarkeit: Pediatric Formulations

Pediatric Formulations: A Roadmap

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Bibliographische Detailangaben
Format:	Elektronisch E-Book
Sprache:	English
Veröffentlicht:	New York, NY [u.a.] Springer [u.a.] 2014
Schriftenreihe:	AAPS Advances in the Pharmaceutical Sciences Series 11
Schlagworte:	Medizin Medicine Pharmaceutical technology Pharmacy Pediatrics Biomedicine
Online-Zugang:	TUM01 UBT01 Volltext Inhaltsverzeichnis Abstract
Beschreibung:	1 Online-Ressource
ISBN:	9781489980113
DOI:	10.1007/978-1-4899-8011-3

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Datensatz im Suchindex

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adam_text	PEDIATRIC FORMULATIONS / : 2014 TABLE OF CONTENTS / INHALTSVERZEICHNIS PEDIATRIC DEVELOPMENT: ANATOMY AGE, WEIGHT, BODY SURFACE AND STATURE, ORGAN DEVELOPMENT PEDIATRIC DEVELOPMENT: PHYSIOLOGY. ENZYMES, DRUG METABOLISM, PHARMACOKINETICS AND PHARMACODYNAMICS PEDIATRIC DEVELOPMENT – GASTROINTESTINAL 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 – THE 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 DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT. PEDIATRIC FORMULATIONS / : 2014 ABSTRACT / INHALTSTEXT 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 FORMULATE” TEXTBOOK FOR PHARMACEUTICAL SCIENTISTS; THE SUBTITLE “A ROADMAP” INDICATES 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 ADULTS” A 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 CHILDREN’S PARENTS 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 DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
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spelling	Pediatric Formulations A Roadmap Daniel Bar-Shalom ; Klaus Rose, ed. New York, NY [u.a.] Springer [u.a.] 2014 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier AAPS Advances in the Pharmaceutical Sciences Series 11 Medizin Medicine Pharmaceutical technology Pharmacy Pediatrics Biomedicine Bar-Shalom, Daniel Sonstige oth Rose, Klaus Sonstige oth Erscheint auch als Druckausgabe 978-1-4899-8010-6 AAPS Advances in the Pharmaceutical Sciences Series 11 (DE-604)BV041360401 11 https://doi.org/10.1007/978-1-4899-8011-3 Verlag Volltext Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027170798&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027170798&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Abstract
spellingShingle	Pediatric Formulations A Roadmap AAPS Advances in the Pharmaceutical Sciences Series Medizin Medicine Pharmaceutical technology Pharmacy Pediatrics Biomedicine
title	Pediatric Formulations A Roadmap
title_auth	Pediatric Formulations A Roadmap
title_exact_search	Pediatric Formulations A Roadmap
title_full	Pediatric Formulations A Roadmap Daniel Bar-Shalom ; Klaus Rose, ed.
title_fullStr	Pediatric Formulations A Roadmap Daniel Bar-Shalom ; Klaus Rose, ed.
title_full_unstemmed	Pediatric Formulations A Roadmap Daniel Bar-Shalom ; Klaus Rose, ed.
title_short	Pediatric Formulations
title_sort	pediatric formulations a roadmap
title_sub	A Roadmap
topic	Medizin Medicine Pharmaceutical technology Pharmacy Pediatrics Biomedicine
topic_facet	Medizin Medicine Pharmaceutical technology Pharmacy Pediatrics Biomedicine
url	https://doi.org/10.1007/978-1-4899-8011-3 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027170798&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027170798&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA
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