TABLE OF CONTENTS
Chapter 1: Executive Summary
- References
Chapter 2: Background
- Introduction
- De.ning Age
- The Elderly
- Pediatric Groups
- Demographic Changes
- Healthcare Expenditure in the Elderly
- Age-Related Diseases: An Increasingly Important Market
- Regulatory Issues
- Regulatory Pressure to Study Pediatric Populations
- Exploratory Investigational New Drug Studies
- Increased Emphasis on Safety
- Biomarkers
- Sources of Information and Scope of Report
- References
Chapter 3: ADME—The Essentials
- What is Pharmacokinetics?
- Absorption
- Transporters
- Distribution
- The Apparent Volume of Distribution (VD)
- Protein Binding
- Metabolism
- Pharmacogenomics and Metabolism
- Drug Transporters and Metabolism
- Excretion
- Variation
- The Problem of Poor Compliance
- Whole-Body Pharmacokinetic Modeling
- Receptor Microscopic Autoradiography
- Non-Linear Pharmacokinetics
- High-Throughput Screening and the Rule of Five
- References
Chapter 4: Age-related Changes in ADME
- Introduction
- Age-Related Physiological Changes in the Elderly that Impact on ADME
- Renal Excretion
- Hepatic Function
- Sources of Age-Related Changes in Children
- Juvenile Animal Studies
- Modi.ed Release and Other Formulation Issues
- Clinical Biomarkers
- References
Chapter 5: In Silico ADME
- Introduction
- Examples of In silico ADME
- Simulations Plus
- MetaDrug
- Lhasa Limited
- VolSurf
- Combinatorial Pharmacology
- PK-Sim
- A Lack of Data Hinders In silico Development
- Insights from Systems Biology
- QSAR and ADME
- References
Chapter 6: Expert Interviews
- Participants
- Questions
- References
Chapter 7: Commercial Considerations
- Introduction
- Market Size
- Impact on the Cost of Drug Development
- References
Chapter 8: Summary and Conclusions
Chapter 9: Company Pro.les
- Accelrys, Inc
- BASi (Bioanalytical Systems, Inc.)
- BioFocus
- Covance Inc.
- DDS Medicines Research Ltd.
- DxS Ltd .
- GeneGo Inc
- Kendle
- Lhasa Limited
- Molecular Devices Corporation
- Nimbus Biotechnologie GmbH
- NoAb BioDiscoveries Inc
- Oxford Genome Sciences (UK) Ltd
- Pharmaceutical Pro.les Group
- Pharmagene Laboratories Limited
- Simulations Plus, Inc
- Tripos, Inc
- References
Chapter 10: References
TABLE OF EXHIBITS
- Exhibit 2.1 Life Expectancy from Birth for Men and Women Born Between 1900 and 2000
- Exhibit 2.2 The Proportion of the Population Aged over 80 Years in Various Countries
- Exhibit 2.3 Healthcare Expenditure in the Elderly in Various Countries
- Exhibit 3.1 Idealized Plasma Concentration Time Curve Showing Some Key Pharmacokinetic Parameters
- Exhibit 3.2 The Effect of SNP in Drug Metabolism Enzyme on the Plasma Concentration-time Curve for a Hypothetical Medicine
- Exhibit 3.3 Patients of Patients Intolerant of Simvastatin Strati.ed by Expression of CYP2D6
- Exhibit 3.4 Examples of SNPs in Drug Metabolizing Enzymes and the Allele Frequency in Various Populations
- Exhibit 3.5 Examples of Some Factors In.uencing Intra-patient Variations in Pharmacokinetics
- Exhibit 3.6 Compliance Rates in Various Conditions
- Exhibit 3.7 Examples of Modi.ed Release Formulations
- Exhibit 3.8 Drug-Target Homunculus
- Exhibit 4.1 The Effect of Age on Plasma Elimination Half-lives
- Exhibit 4.2 Factors that Could In.uence ADME in Preterm Infants and Neonates Born at Term
- Exhibit 4.3 Examples of Physiological Functions that May In.uence Pharmacokinetic Differences between Infants and Adults
- Exhibit 4.4 Body Composition in Neonates and Adults
- Exhibit 5.1 Clinical Data and GastroPlus Simulation for Oral Administration of Gabapentin to Pediatric Subjects with Average Age of 6 years
- Exhibit 5.2 Observed Clearance in Children versus Clearance as Predicted with PK-Sim
- Exhibit 5.3 Simulated Plasma Concentration Curves of Levo.oxacin and Morphine for Children for Different Age Groups Compared to the Corresponding Experimental Data
- Exhibit 5.4 A Hypothetical Example of a Network
- Exhibit 5.5 Types of QSAR Analyses .
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