Pediatric Formulations - (Aaps Advances in the Pharmaceutical Sciences) by Daniel Bar-Shalom & Klaus Rose (Paperback)
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<p/><br></br><p><b> Book Synopsis </b></p></br></br><p><b>Part I: The Patient</b> </p><p>1. Pediatric Development: Anatomy. Age, Weight, Body Surface and Stature, Organ Development</p><p><i>Hannah Bachelor</i> </p><p>2. Pediatric Development: Physiology. Enzymes; Drug Metabolism; Pharmacokinetics & Pharmacodynamics</p><p><i>Geert 't Jong</i> </p><p>3. Pediatric Development - Gastrointestinal </p><p><i>Hannah Batchelor</i> </p><p>4. How to Estimate the Dose to be Given for the First Time to Pediatric Patients</p><p><i>Gerard Greig</i></p><p>5. The Clinical Relevance of Pediatric Formulations </p><p><i>Karel Allegaert, Pieter De Cock, Johannes N van den Anker</i> </p><p><b>Part II: Formulating for Children I, The Oral Route</b> </p><p>6. General Considerations for Pediatric Oral Drug Formulation</p><p><i>Valentina Shakhnovich and Susan M. Abdel-Rahman<sup></sup></i></p><p>7. Orosensory Perception</p><p><i>Per Møller</i></p><p>8. Flavor Is Not Just Taste: Taste Concealing</p><p><i>Charles R. Frey</i></p><p>9. Liquid Formulations</p><p><i>Charles R. Frey and J. Scott Madsen</i></p><p>10. Paediatric Solid Formulations</p><p><i>Sejal Ranmal and Catherine Tuleu</i></p><p>11. Semi-Solid Formulations</p><p><i>Daniel Bar-Shalom and Irwin C. Jacobs</i></p><p>12. The Challenge of Automated Compounding </p><p><i>Daniel Bar-Shalom</i></p><p>13. Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation </p><p><i>Norbert Pöllinger</i></p><p>14. Buccal/Sublingual Drug Delivery for the Paediatric Population</p><p><i>Viralkumar F. Patel, Darragh Murnane, Marc B. Brown</i></p><p><b>Part III: Formulating for Children II, Non-Oral Routes</b> </p><p>15. Topical and Transdermal </p><p><i>William McAuley, Matthew Traynor</i><i> and Marc Brown</i> </p><p>16. Parenteral Liquids for Intravenous and Transdermal Use</p><p><i>Utpal U. Shah and Matthew Roberts</i></p><p>17. The Challenges of Paediatric Pulmonary Drug Delivery </p><p><i>Darragh Murnane and Marc B Brown</i></p>18. Nasal, Ocular, and Otic Drug Delivery <p><i>Hannah Batchelor</i></p>19. Rectal Drug Delivery <p><i>Hannah Batchelor</i></p>20. Intraosseous Infusions in Infants and Neonates<p><i>Jose Ramet, Maria A.L.J. Slaats Mst, Catharina J. Elsing Mst<sup></sup></i></p><p><b>Part IV: </b><b>Compounding</b> </p><p>21. Compounding for Children - The Compounding Pharmacist</p><p><i>Linda F. McElhiney</i></p><p><b>Part V: Materials</b> </p><p>22. Food Ingredients</p><p><i>Parnali Chatterjee and Marie Ojiambo</i></p><p>23. Excipients and Active Pharmaceutical Ingredients (APIs) </p><p><i>Parnali Chatterjee and Mohammed M Alvi</i></p><p><b>Part VI: Clinical Development and Regulatory Aspects</b> </p><p>24. Clinical Testing in Children </p><p><i>Klaus Rose</i> </p><p>25. Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the United States and Implementation of Quality by Design </p><p><i>Arzu Selen</i></p> <p>26. Pediatric Pharmaceutical Legislation and its impact on Adult and Pediatric Drug Development: The EU Regulatory View<br><i>Siri Wang & Karl-Heinz Huemer</i></p><p>27. Pediatric Pharmaceutical Legislation in USA and EU and their impact on Adult and Pediatric Drug Development</p><p> <i>Klaus Rose</i> </p><p>28. Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation</p><p><i>Rosita Agnew</i></p><p><b>Part VII: Concluding Remarks - The Future of Pediatric Formulations </b></p><p>29. The Dangerous Business Of Predicting The Future </p> <p><i>Daniel Bar-Shalom. Hannah Batchelor, Linda F. McElhiney, Klaus Rose</i></p><p/><br></br><p><b> From the Back Cover </b></p></br></br><p>As the first book that specifically addresses pediatric formulations in the context of drug development, <i> Pediatric Formulations: A Roadmap</i> 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. </p> <p>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.</p><p><b>Daniel Bar-Shalom</b> 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. </p> <p><b></b></p><p><b>Dr. Klaus Rose </b>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. </p><p/><br></br><p><b> Review Quotes </b></p></br></br><br><p>From the reviews: </p>"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)<br><p/><br></br><p><b> About the Author </b></p></br></br><p>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.</p><p>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.</p>
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