عنوان

Fundamentals of pediatric drug dosing /

3319437542

9783319437545

3319437526

9783319437521

b433287

Fundamentals of pediatric drug dosing /

[Book]

Iftekhar Mahmood, Gilbert Burckart, editors

1 online resource

Preface; Contents; Chapter 1: Pediatric Drug Development and the Regulatory Changes That Are Creating the Science of Pediatric Dosing; 1.1 Introduction; 1.1.1 Problems in Designing Pediatric Drug Development Studies; 1.1.1.1 Identification of the Appropriate Pediatric Dose; 1.1.1.2 Failed Trials; 1.1.1.3 Matching Drug Exposure to Adult Exposure; 1.1.1.4 Extrapolation of Efficacy; 1.1.1.5 Dedicated PK Studies; 1.1.1.6 Use of Modeling and Simulation; 1.1.1.7 Pediatric Studies in Special Populations; 1.1.1.8 Pediatric Study Design Issues

1.2 Examples of Lessons Learned from Pediatric Studies Conducted Under BPCA and PREA1.2.1 Example: Dose Selection; 1.2.2 Example: Dose Finding for a Pediatric Indication That Is Different from the Adult Indication; 1.2.3 Example: Trial Design Regarding Cmax-Matching and Controlling for the Placebo Effect; 1.2.4 Example: Trial Design and Study Planning to Achieve a Labeled Pediatric Indication; 1.3 The Path Ahead Under FDASIA; 1.4 Summary; References; Chapter 2: Pediatric Physiology; 2.1 Classification of Age Groups; 2.2 Body Weight; 2.3 Body Surface Area; 2.4 Organ Weights

2.5 Pediatric Anatomy and Physiology2.5.1 Head; 2.5.2 Nervous System; 2.5.3 Cardiovascular System; 2.5.4 Chest and Lungs; 2.5.5 Abdomen; 2.5.6 Total Body Water; 2.5.7 Enzymatic Activity; 2.5.8 Renal Excretion; 2.5.9 Skin Physiology; 2.6 Pediatric Obesity; 2.7 Body Mass Index (BMI) and the Detection of the Degree of Obesity in Individual Obese Children and Adolescents; 2.8 Pharmacokinetics in Obese Children; References; Chapter 3: Developmental Pharmacology: Impact on Pharmacokinetics and Pharmacodynamics of Drugs; 3.1 Introduction; 3.2 Absorption; 3.3 Distribution; 3.3.1 Body Composition

3.3.2 Protein Binding3.3.3 Prediction of Protein Binding in Infants; 3.3.4 Erythrocytes and Tissue Binding; 3.3.5 Blood-Brain Barrier and Membrane Permeability; 3.4 Metabolism; 3.4.1 Phase I Drug Metabolizing Enzymes; 3.4.1.1 CYP3A; 3.4.1.2 CYP1A2; 3.4.1.3 CYP2C9 and CYP2C19; 3.4.1.4 CYP2D6; 3.4.2 Phase II Drug Metabolizing Enzymes; 3.4.2.1 Glucuronide Conjugation; 3.4.2.2 Glutathione Conjugation; 3.4.2.3 Sulfate Conjugation; 3.4.2.4 Acetylation; 3.4.2.5 Aldehyde Oxidase; 3.4.2.6 Monoamine Oxidases; 3.4.2.7 Bile Acids; 3.5 Renal Elimination; 3.5.1 Glomerular Filtration

3.5.2 Tubular Secretion3.5.3 Tubular Reabsorption; 3.6 Measurement of Renal Function; 3.6.1 Cockroft-Gault (>12 years); 3.6.2 Schwartz (Infants <1 Year); 3.6.3 Schwartz (Children 1-12 Years); 3.6.4 Modified Schwartz Equations; 3.6.5 Height-Independent Equation; 3.7 Chirality; 3.7.1 Ketorolac; 3.7.2 Tramadol; 3.7.3 Warfarin; 3.7.4 Ibuprofen; 3.8 Pharmacodynamics in Children; 3.8.1 In Vivo Warfarin Study; 3.8.2 In Vitro Cyclosporine Study; 3.8.3 Regional Hemodynamic Effect of Dopamine in Preterm Neonates; 3.8.4 Lansoprazole; 3.9 Conclusions; References

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Focused on pediatric physiology, pharmacology, pharmacokinetics and pharmacodynamics, this book illustrates the differences between the pediatric population and adults; knowledge of extreme importance not only during pediatric drug development but also in the clinical practice. Physicians, nurses, clinical pharmacologists, researchers and healthcare professionals will find this an invaluable resource. With the advent of pediatric exclusivity, and requirements to conduct clinical studies in children, an emphasis has been placed on finding a safe and efficacious dose of a drug in children. Children are not 'small adults', and drug dosing in this population requires special consideration. There are subtle physiological and biochemical differences among neonates, infants, children, adolescents and adults and dosing in pediatrics requires proper understanding of these factors. Furthermore, dosing in children, as in adults, should be based on pharmacokinetic and pharmacodynamic data. This is an evolving area, as pediatric pharmacokinetic studies are becoming mandatory for getting approval of new drugs in this population

9783319437521

Drugs-- Dosage.

Pediatric pharmacology.

MED-- 071000

Burckart, Gilbert

Mahmood, Iftekhar

Ohio Library and Information Network.

20161111052131.3

pn

[Book]

Y