Pediatric Formulations: A Roadmap
Saved in:
| Format: | Electronic eBook |
|---|---|
| Language: | English |
| Published: |
New York, NY [u.a.]
Springer [u.a.]
2014
|
| Series: | AAPS Advances in the Pharmaceutical Sciences Series
11 |
| Subjects: | |
| Online Access: | TUM01 UBT01 Volltext Inhaltsverzeichnis Abstract |
| Physical Description: | 1 Online-Ressource |
| ISBN: | 9781489980113 |
| DOI: | 10.1007/978-1-4899-8011-3 |
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| 245 | 1 | 0 | |a Pediatric Formulations |b A Roadmap |c Daniel Bar-Shalom ; Klaus Rose, ed. |
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Record in the Search Index
| _version_ | 1804152003430973440 |
|---|---|
| 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 |
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