Produktbild: Pediatric Formulations
Band 11

Pediatric Formulations A Roadmap

171,19 €

inkl. gesetzl. MwSt.

Beschreibung

Produktdetails

Format

PDF

Kopierschutz

Nein

Family Sharing

Nein

Text-to-Speech

Nein

Erscheinungsdatum

30.01.2014

Herausgeber

Daniel Bar-Shalom + weitere

Verlag

Springer New York

Seitenzahl

439 (Printausgabe)

Dateigröße

6488 KB

Sprache

Englisch

EAN

9781489980113

Beschreibung

Rezension

From the reviews:

“This book can be useful not only for those in drug development, but also for pharmacists who work in pediatrics (either hospital or community pharmacists), compounding pharmacists, pediatricians, nurses who specialize in this area, and certainly students or residents in any of these disciplines who plan to focus on pediatrics. … I have reviewed and used many books on drug formulations and pharmaceutics, but I have not seen such a complete book devoted specifically to pediatrics.” (Patrick J. McDonnell, Doody’s Book Reviews, July, 2014)

Portrait

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.

Produktdetails

Format

PDF

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Kopierschutz

Nein

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Text-to-Speech

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Barrierefreiheit

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Erscheinungsdatum

30.01.2014

Herausgeber

Verlag

Springer New York

Seitenzahl

439 (Printausgabe)

Dateigröße

6488 KB

Sprache

Englisch

EAN

9781489980113

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  • Produktbild: Pediatric Formulations
  • Part I: The Patient

    1. Pediatric Development: Anatomy. Age, Weight, Body Surface and Stature, Organ Development

    Hannah Bachelor 

    2. Pediatric Development: Physiology. Enzymes; Drug Metabolism; Pharmacokinetics & Pharmacodynamics

    Geert 't Jong

    3. Pediatric Development - Gastrointestinal 

    Hannah Batchelor

    4. How to Estimate the Dose to be Given for the First Time to Pediatric Patients

    Gerard Greig

    5. The Clinical Relevance of Pediatric Formulations

    Karel Allegaert , Pieter De Cock , Johannes N van den Anker

    Part II: Formulating for Children I, The Oral Route

    6. General Considerations for Pediatric Oral Drug Formulation

    Valentina Shakhnovich and  Susan M. Abdel-Rahman

    7. Orosensory Perception

    Per Møller

    8. Flavor Is Not Just Taste: Taste Concealing

    Charles R. Frey

    9. Liquid Formulations

    Charles R. Frey and J. Scott Madsen

    10. Paediatric Solid Formulations

    Sejal Ranmal and Catherine Tuleu

    11. Semi-Solid Formulations

    Daniel Bar-Shalom and Irwin C. Jacobs

    12. The Challenge of Automated Compounding

    Daniel Bar-Shalom

    13. Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation

    Norbert Pöllinger

    14. Buccal/Sublingual Drug Delivery for the Paediatric Population

    Viralkumar F. Patel, Darragh Murnane, Marc B. Brown

    Part III: Formulating for Children II, Non-Oral Routes

    15. Topical and Transdermal

    William McAuley, Matthew Traynor and Marc Brown

    16. Parenteral Liquids for Intravenous  and Transdermal Use

    Utpal U. Shah and Matthew Roberts

    17. The Challenges of Paediatric Pulmonary Drug Delivery

    Darragh Murnane and Marc B Brown

    18. Nasal, Ocular,and Otic Drug Delivery

    Hannah Batchelor

    19. Rectal Drug Delivery

    Hannah Batchelor

    20. Intraosseous Infusions in Infants and Neonates

    Jose Ramet, Maria A.L.J. Slaats Mst, Catharina J. Elsing Mst

    Part IV: Compounding

    21. Compounding for Children - The Compounding Pharmacist

    Linda F. McElhiney

    Part V: Materials

    22. Food Ingredients

    Parnali Chatterjee and Marie Ojiambo

    23. Excipients and Active Pharmaceutical Ingredients (APIs)

    Parnali Chatterjee and Mohammed M Alvi

    Part VI: Clinical Development and Regulatory Aspects

    24. Clinical Testing in Children

    Klaus Rose 

    25. Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the United States and Implementation of Quality by Design    

    Arzu Selen

    26. Pediatric Pharmaceutical Legislation and its impact on Adult and Pediatric Drug Development: The EU Regulatory View Siri Wang & Karl-Heinz Huemer

    27. Pediatric Pharmaceutical Legislation in USA and EU and their impact on Adult and Pediatric Drug Development

     Klaus Rose

    28. Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation

    Rosita Agnew

    Part VII: Concluding Remarks - The Future of Pediatric Formulations

    29. The Dangerous Business Of Predicting The Future

    Daniel Bar-Shalom. Hannah Batchelor, Linda F. McElhiney, Klaus Rose