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Therapeutic Drug Monitoring - Technologies, Markets, and Companies Product Image

Therapeutic Drug Monitoring - Technologies, Markets, and Companies

  • ID: 2074117
  • September 2014
  • Region: Global
  • 180 Pages
  • Jain PharmaBiotech

This report deals with therapeutic drug monitoring, a multi-disciplinary clinical specialty, aimed at improving patient care by monitoring drug levels in the blood to individually adjust the dose of drugs for improving outcome. TDM is viewed as a component of personalized medicine that interacts with several other disciplines including pharmacokinetics and pharmacogenetics. One chapter is devoted to monitoring of drugs of abuse (DoA). Various technologies used for well-known DoA are described. A section on drug abuse describes methods of detection of performance-enhancing drugs. TDM market is analyzed from 2013 to 2023 according to technologies as well as geographical distribution. Global market for DoA testing was also analyzed from 2012 to 2022 and divided according to the area of application. Unmet needs and strategies for development of markets for TDM are discussed. The report contains profiles of 27 companies involved in developing tests and equipment for drug monitoring along with their collaborations. The text is supplemented with 17 tables, 6 figures and 180 selected references from literature.

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0. Executive Summary

1. Introduction
Definitions
Historical Landmarks in the development of TDM
Pharmacology relevant to TDM
Pharmacokinetics
Pharmacodynamics
Pharmacogenetics
Pharmacogenomics
Pharmacoproteomics
Drug receptors
Protein binding
Therapeutic range of a drug
Variables that affect TDM
Indications for TDM
Multidisciplinary nature of TDM

2. Technologies for TDM
Introduction
Sample preparation
Proteomic technologies
Mass spectrometry
Liquid chromatography MS
Matrix-Assisted Laser Desorption/Ionization Mass Spectrometry
Combining capillary electrophoresis with MS
Gas-liquid chromatography
Tissue imaging mass spectrometry
New trends in sample preparation
Pressure Cycling Technology
Desorption electrospray ionization imaging
Analysis of dried blood spots for drugs using DESI
High Performance Liquid Chromatography (HPLC)
Ultra performance LC
Paper spray
Quantitative analysis of drugs in dried blood spot by paper spray MS
Immunoassays
Enzyme-linked immunosorbent assay
Cloned Enzyme Donor Immunoassay
Enzyme Multiplied Immunoassay Technique
Fluorescence Polarization Immunoassay
Particle Enhanced Turbidimetric Inhibition Immunoassay
Radioimmunometric assays
Biosensors
Nanosensors
Biochips & Microarrays
Introduction
Microchip capillary electrophoresis
Phototransistor biochip biosensor
Microchip-based fluorescence polarization immunoassay for TDM
Cellular microarrays
Microfluidics for TDM
Lab-on-a-chip
Micronics' microfluidic technology
Rheonix CARD technology
Nano-interface in a microfluidic chip
Levitation of nanofluidic drops with physical forces
Nanoarrays
Nanobiotechology
NanoDx™
Biomarkers
Applications of biomarkers in drug safety studies
Genomic technologies for toxicology biomarkers
Proteomic technologies for toxicology biomarkers
Metabonomic technologies for toxicology biomarkers
Integration of genomic and metabonomic data to develop toxicity biomarkers
Toxicology studies based on biomarkers
Biomarkers of hepatotoxicity
Biomarkers of nephrotoxicity
Cardiotoxicity
Neurotoxicity
Biomarkers in clinical trials
Molecular diagnostics
Molecular imaging

3. Drug Monitoring Instruments
Introduction
Description of important instruments
AB SCIEX instruments
AB SCIEX LC/MS/MS
Abbott instruments
ARCHITECT c16000
ARCHITECT c4000
ARCHITECT c8000
ARCHITECT ci16200 Integrated System
ARCHITECT ci4100 Integrated System
ARCHITECT ci8200 integrated with the ARCHITECT i2000SR
ARCHITECT i1000SR
ARCHITECT i4000SR
AxSYM
Agilent’s 6400 Series Triple Quadrupole LC/MS
Alfa Wassermann’s ACE Alera
AMS Diagnostics’ LIASYS
Awareness Technology’s STAT FAX 4500
Beckman Coulter instruments
Beckman Coulter Unicel Series
AU5800 automated chemistry systems
AU480
Binding Site ESP600
bioMerieux Mini Vidas
Carolina BioLis 24i
Chromsystems’ HPLC instruments
Grifols Triturus
ABX Pentra 400
Medica EasyRA
Nova Biomedical Critical Care Xpress
Ortho Clinical Diagnostics’ VITROS® family of systems
Immunodiagnostic systems
Randox intruments
Randox RX Imola
Roche instruments
Cobas® 8000
COBAS INTEGRA® Systems
Siemens instruments
ADVIA 1200
ADVIA Centaur XP immunoassay system
EMIT® II Plus Syva®
Viva® Drug Testing Systems
Dimension® Xpand® Plus Integrated Chemistry System
Thermo Scientific instruments
Indiko
Tosoh AIA-Series

4. Applications of TDM
Introduction
Pharmaceutical research and drug development
Clinical trials
Genotyping for polymorphisms of genes affecting drug metabolism
Computerized clinical decision support systems for TDM and dosing
TDM in special groups
The aged
Children
Pregnancy
TDM of prophylactic therapy
Monitoring of vitamin D levels
Monitoring of RBC folic acid levels during pregancy
Personalized medicine
Role of TDM in personalized medicine
Applications according to various conditions
Anesthesia and critical care
Optimizing antimicrobial dosing for critically ill patients
TDM monitoring of thiopental continuous infusion in critical care
Role of TDM in critical care cardiac patients.
Cancer
Cardiovascular disorders
Epilepsy
Personalized approach to use of AEDs
Infections
Virus infections
Fungal infections
Pain
Role of TDM in pain management
AEDs as analgesics
Triptans for migraine
Psychiatric disorders
Transplantation
TDM of Tacrolismus in transplantation
TDM of cyclosporine A in transplantation
Monitoring of immunosuppression with mycophenolate mofetil
Emergency toxicology
Future prospects of TDM

5. Drugs Requiring Monitoring
Introduction
Antiepileptics
Carbamazepine
TDM of carbamazepine
Gabapentin
Lamotrigine
TDM of lamotrigine
Levetiracetam
TDM of levetiracetam
Phenobarbital
TDM of phenobarbital
Phenytoin
TDM of phenytoin
Primidone
TDM of primidone
Topiramate
TDM of topiramate
Valproic acid
TDM of valproic acid
TDM of multiple antiepileptic drugs in plasma/serum
Antimicrobials
Antibiotics
Amikacin
Anti-tuberculosis drugs
Chloramphenicol
Gentamicin
Tobramycin
Vancomycin
Norvancomycin
Antiviral agents
Anti-HIV drugs
Antifungal agents
Voriconazole
Antidepressants
TDM of selective serotonin reuptake inhibitors
Antipsychotics
Aripiprazole
Quetiapine
TDM of risperidone
TDM of AEDs in psychiatric disorders
TDM of multiple drugs in psychiatry
Bronchodilators
Theophylline
Cardiovascular drugs
Antiarrhythmic drugs
Anticoagulants
Dabigatran
Antihypertensive drugs
ß-blockers
Cardiotonic drugs
Digoxin
TDM of statins for hypercholesterolemia
Chemotherapy for cancer
Methotrexate
Drugs used for treatment of Alzheimer disease
Donepezil
Galantamine
Memantine
Drugs for treatment of attention-deficit hyperactivity disorder
Atomoxetine
Methylphenidate
Hypnotic-sedative drugs
Benzodiazepines
Propofol
Immunosuppressive drugs
TDM of mycophenolic acid for the treatment of lupus nephritis
Steroids
Prednisone
Miscellaneous drugs
Azathioprine
Catechol-O-methyltransferase inhibitors
Sildenafil

6. Monitoring of Biological Therapies
Introduction
Cell therapy
In vivo tracking of cells
Molecular imaging for tracking cells
MRI technologies for tracking cells
Superparamagnetic iron oxide nanoparticles as MRI contrast agents
Visualization of gene expression in vivo by MRI
Gene therapy
Application of molecular diagnostic methods in gene therapy
Use of PCR to study biodistribution of gene therapy vector
PCR for verification of the transcription of DNA
In situ PCR for direct quantification of gene transfer into cells
Detection of retroviruses by reverse transcriptase (RT)-PCR
Confirmation of viral vector integration
Monitoring of gene expression
Monitoring of gene expression by green fluorescent protein
Monitoring in vivo gene expression by molecular imaging
Monoclonal antibodies
Natalizumab

7. Monitoring of Drug Abuse
Introduction
Tests used for detection of drug abuse
MS for doping control
Randox assays for DoA
Drugs of Abuse Array V
Urine drug testing
TDM of drugs for treatment of substance abuse-related disorders
Drug testing to monitor treatment of drug abuse
Minimum requirement for drug testing in patients
Analgesic abuse
?-blockers as doping agents
Detection of ß-blockers in urine
Chronic alcohol abuse
Cocaine
CEDIA for cocaine in human serum
Detection of cocaine molecules by nanoparticle-labeled aptasensors
Infrared spectroscopy for detection of cocaine in saliva
Marijuana
Use of marijuana and synthetic cannabinoids
Detection of cannabinoids
ELISA for detection of synthetic cannabinoids
Drug abuse for performance enhancement in sports
Historical aspects of drug abuse in sports
Drugs used by athletes for performance enhancement
Techniques used for detection of drug abuse by athletes
Mass spectrometry for detection of peptide hormones
miRNAs for the detection of erythropoiesis-stimulating agents
Detection of anabolic steroids
Body fluids and tissues used for detection of drug abuse in sports
Urine drug testing
Spray (sweat) drug test kits
Hair drug testing
Gene doping in sports
Gene transfer methods used for enhancing physical performance
Misuse of cell therapy in sport
Challenges of detecting genetic manipulations in athletes
Drug abuse testing in race horses
Limitations and future prospects
Role of pharmaceutical industry in anti-doping testing

8. Markets for TDM
Introduction
Methods for market estimation and future forecasts
Markets for TDM tests
Markets for TDM and DoA testing equipment
Geographical distribution of markets for TDM tests
Drivers for growth of TDM markets
Markets for DoA testing
Unmet needs in TDM
Cost-benefit studies
Simplifying assays and reducing time and cost
Strategies for developing markets
Physician education
Supporting research on TDM
Biomarker patents for drug monitoring

9. Companies
Profiles of companies
Collaborations

10. References

Tables
Table 1-1: Historical landmarks in the development of therapeutic drug monitoring
Table 5-1: Drugs requiring TDM
Table 5-2: Indications and therapeutic ranges of various AEDs
Table 6-1: Molecular imaging methods for tracking cells in vivo
Table 6-2: Applications of molecular diagnostics in gene therapy
Table 7-1: Commonly tested drugs of abuse and recreational drugs
Table 7-2: Testing and confirmation cutoff concentrations/detection times for DoA
Table 7-3: Historical landmarks of drug abuse in sports
Table 7-4: Drugs used by athletes for performance enhancement
Table 7-5: Genes that may be used for performance enhancement
Table 8-1: Global markets for TDM according to technologies from 2013-2023
Table 8-2: Markets for TDM and DoA testing equipment 2013-2023
Table 8-3: Geographical distribution of markets for TDM tests 2013-2023
Table 8-4: Drivers for growth of TDM markets
Table 8-5: Global markets for DoA testing 2013-2023
Table 9-1: Drugs for which monitoring and detection tests are provided by LabCorp
Table 9-2: Collaborations of companies involved in TDM

Figures
Figure 1-1: Therapeutic range of a drug
Figure 1-2: Flow chart of TDM
Figure 1-3: Interrelationships of TDM
Figure 2-1: Basic principle of a biosensor
Figure 8-1: Unmet needs in TDM
Figure 8-2: Metabolism of azathioprine and biomarkers for TDM

Professor K. K. Jain is a neurologist/neurosurgeon by training and has been working in the biotechnology/biopharmaceuticals industry for several years. He received graduate training in both Europe and USA, has held academic positions in several countries and is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of UK. Currently he is a consultant at Jain PharmaBiotech. Prof. Jain is the author of 415 publications including 16 books (2 as editor) and 48 special reports, which have covered important areas in biotechnology, gene therapy and biopharmaceuticals.

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