Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives

H Derendorf, B Meibohm - Pharmaceutical research, 1999 - Springer
Abstract Pharmacokinetic/pharmacodynamic (PK/PD)-modeling links dose-concentration
relationships (PK) and concentration-effect relationships (PD), thereby facilitating the …

Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies

LJ Lesko, AJ Atkinson Jr - Annual review of pharmacology and …, 2001 - annualreviews.org
In the future, biomarkers will play an increasingly important role in all phases of drug
development, including regulatory review. However, only a few of these biomarkers will …

Sobol sensitivity analysis: a tool to guide the development and evaluation of systems pharmacology models

XY Zhang, MN Trame, LJ Lesko… - CPT: pharmacometrics & …, 2015 - Wiley Online Library
A systems pharmacology model typically integrates pharmacokinetic, biochemical network,
and systems biology concepts into a unifying approach. It typically consists of a large …

Pharmacokinetic aspects of biotechnology products

L Tang, AM Persky, G Hochhaus, B Meibohm - Journal of pharmaceutical …, 2004 - Elsevier
In recent years, biotechnologically derived peptide and protein-based drugs have
developed into mainstream therapeutic agents. Peptide and protein drugs now constitute a …

Pharmacokinetics/pharmacodynamics of bisphosphonates: use for optimisation of intermittent therapy for osteoporosis

SCLM Cremers, G Pillai, SE Papapoulos - Clinical pharmacokinetics, 2005 - Springer
Bisphosphonates suppress osteoclast-mediated bone resorption and are widely used in the
management of osteoporosis. Daily oral administration of alendronic acid and risedronic …

The role of drug transporters at the blood-brain barrier

AG De Boer, ICJ Van Der Sandt… - Annual review of …, 2003 - annualreviews.org
The blood-brain barrier (BBB) is a dynamic interface between the blood and the brain. It
eliminates (toxic) substances from the endothelial compartment and supplies the brain with …

Mechanism-based pharmacokinetic-pharmacodynamic modeling: biophase distribution, receptor theory, and dynamical systems analysis

M Danhof, J de Jongh, ECM De Lange… - Annu. Rev …, 2007 - annualreviews.org
Mechanism-based PK-PD models differ from conventional PK-PD models in that they
contain specific expressions to characterize, in a quantitative manner, processes on the …

Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development

S Schneeweiss, JJ Gagne, RJ Glynn… - Clinical …, 2011 - Wiley Online Library
Comparative‐effectiveness research (CER) aims to produce actionable evidence regarding
the effectiveness and safety of medical products and interventions as they are used outside …

Pharmacokinetic/pharmacodynamic modeling in drug research and development

H Derendorf, LJ Lesko, P Chaikin… - The Journal of …, 2000 - Wiley Online Library
The two domains in clinical pharmacology dealing with optimizing dosing recommendations
are pharmacokinetics and pharmacodynamics. However, the usefulness of these disciplines …

[HTML][HTML] Extensions to the visual predictive check to facilitate model performance evaluation

TM Post, JI Freijer, BA Ploeger, M Danhof - Journal of pharmacokinetics …, 2008 - Springer
Abstract The Visual Predictive Check (VPC) is a valuable and supportive instrument for
evaluating model performance. However in its most commonly applied form, the method …