173. Pediatric Clinical Pharmacology

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173. Pediatric Clinical Pharmacology

173. Pediatric Clinical Pharmacology

 

 

CATEGORY: Medical & Medicine – 500 Courses

COURSE NUMBER: 173

FEES: 555/- INR only

CERTIFICATE VALIDITY: Lifetime

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BOOKS/ MANUALS: Pages

Syllabus

Part I General Considerations and Methodological Aspects
Basics and Dynamics of Neonatal and Pediatric Pharmacology ……….. 3
Hannsjorg W. Seyberth and Ralph E. Kauffman
Developmental Pharmacokinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Johannes N. van den Anker, Matthias Schwab, and Gregory L. Kearns
Principles of Therapeutic Drug Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Wei Zhao and Evelyne Jacqz-Aigrain
Drug Delivery and Formulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Jorg Breitkreutz and Joachim Boos
Part II Development of Pediatric Medicines
Development of Paediatric Medicines: Concepts and Principles . . . . . . . . . 111
Klaus Rose and Oscar Della Pasqua
Study Design and Simulation Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Stephanie Laer and Bernd Meibohm
Efficacy Assessment in Paediatric Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Siri Wang and Pirjo Laitinen-Parkkonen
Safety Assessment in Pediatric Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Gideon Koren, Abdelbasset Elzagallaai, and Fatma Etwel

Small Sample Approach, and Statistical
and Epidemiological Aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Martin Offringa and Hanneke van der Lee
Sample Collection, Biobanking, and Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Maurice J. Ahsman, Dick Tibboel, Ron A. A. Mathot,
and Saskia N. de Wildt
Ethical Considerations in Conducting Pediatric Research . . . . . . . . . . . . . . . 219
Michelle Roth-Cline, Jason Gerson, Patricia Bright,
Catherine S. Lee, and Robert M. Nelson
Pediatric Regulatory Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Steven Hirschfeld and Agnes Saint-Raymond
Part III Specific Pediatric Pharmacology
Fetal Medicine and Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271
Magnus Westgren
Fetal Risks of Maternal Pharmacotherapy: Identifying Signals . . . . . . . . . 285
Gideon Koren
Antiepileptic Treatment in Pregnant Women: Morphological
and Behavioural Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295
Torbjorn Tomson and Dina Battino
Preventive Medicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 317
Ulrich Heininger
Postmarketing Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339
Vera Vlahovic -Palcevski and Dirk Mentzer
Global Aspects of Drug Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 353
Kalle Hoppu and Hans V. Hogerzeil
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 373

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