2^nd International Conference on Clinical Trials and Therapeutic Drug Monitoring August 22-24, 2016 Philadelphia, Pennsylvania, USA

We welcome you to the 2nd International Conference on  Clinical Trials and Therapeutic Drug Monitoring which is scheduled to be held during August 22-24, 2016 at Philadelphia, USA.

Drug monitoring conferences has theme as “Discoveries and Developments for Safer Medications”. The focus will be mainly on the Therapeutic Drug Monitoring and Toxicogenomics, factors influencing them, challenges, methods followed, rapidly-emerging techniques and their applications.Therapeutic drug monitoring means concentrations of drugs in body fluids, usually plasma, this can be used for diagnostic purposes and during treatment. The selection of drugs for therapeutic drug monitoring is important as the effects of many drugs is not clearly related to their concentrations. Therapeutic drug monitoring is the  clinical practice of measuring concentration of specific drugs in a patient's bloodstream at designated intervals to maintain a constant concentration, thereby optimizing individual dosage regimens. Quantification of Drugs using the analytical methods helps in predicting the toxicological effects.

Drug Monitoring

Therapeutic drug monitoring is defined as the clinical laboratory measurement of a chemical parameter that will directly influence drug prescribing procedures after appropriate medical interpretation. TDM refers to maintaining blood drug or plasma concentrations within a targeted therapeutic range or window for the individualization of drug dosage. Drug Monitoring begins after the drug is first prescribed, and involves determining an initial dosage regimen appropriate for the clinical condition and patient characteristics like age, organ function, weight and concomitant drug therapy.

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Pharmacokinetics & Pharmacodynamics

Pharmacokinetics involves the measurement of the time course of drug absorption, distribution, metabolism and excretion. Clinical pharmacokinetics means the application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in an individual patient. Pharmacodynamics means the relationship between drug concentration at the site of action and the resulting effect, intensity of therapeutic and adverse effects and including the time course. Therapeutic treatment requires information on both pharmacokinetics and pharmacodynamics to understand interpatient variability and how to prescribe dosage for body size, age, or genetic traits. Clinical pharmacokinetic drug trials when compiled for numerous drugs can reveal metabolism and excretion differences across age groups. If sufficient clinical pharmacokinetic data is available, it may be possible to make inferences about the handling of environmental toxicants in a particular age group.

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Gender & Pathophysiology

The ADME of a drug determines the Serum Concentration of a particular drug. Serum drug concentration  is mainly affected by characteristics like genetic makeup, pathophysiology condition and various other factors. The metabolism of drugs in patient with renal failure may slowly clears a drug in urine than a patient with normal renal function. Pregnancy state in women alters the drug metabolism and drug-drug interactions may also alter serum drug concentration. Anatomical variations and different metabolism rates of specific drugs in men and women may show both pharmacokinetic and pharmacodynamics differences.

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Individual Drugs TDM

Anti-epileptic drugs have a narrow therapeutic range as they are strongly bound to serum proteins. Cardio active drugs Digoxin which is frequently used has a narrow therapeutic window. The immunoassays employed in monitoring concentration of serum digoxin are subjected to interference from both exogenous and endogenous compounds. Anti-asthmatic drugs like theophylline and caffeine also require Therapeutic Drug Monitoring. Antidepressants monitoring is essential to avoid drug toxicity. Immunosuppressant’s Whole blood concentration is determined to avoid drug toxicity as well as subtherapeutic levels which may lead to organ rejection. Antibiotics like aminoglycoside produce Nephrotoxicity and Ototoxicity for which they are monitored.

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Drug Quantification

Drug assay methods should have adequately sensitivity. They should be specific to the drug metabolites which has to be measured and should be accurate and precise. Most of the high-volume drug assays are now performed with the automated immunoassay methods which possess these characteristics. However, many a number continue to require manual assay procedures like HPLC and GLC (e.g. amiodarone, perhexiline). Depending on the equipment used, plasma or serum are usually used for drug assays.

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TDM Challenges 

Therapeutic Drug Monitoring depends on Chemical Analysis, Pharmacokinetics and Pharmacodynamics. By determining the nature of the problem to be solved, appropriate methodology to solve the problem, developing applicable analytical schemes that have to be performed competently with good quality and interpreted within the framework, analytical goals in therapeutic drug monitoring should be established. If plasma drug concentration measurements are to be of any particular value, blood sampling timing, the type of blood sample, the measurement technique, and the interpretation of results are to be done with attention. After dosing, it is crucial to obtain the blood sample for measuring the drug concentration at the correct time. Errors in the sampling times are likely responsible for the errors in interpreting the results.

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TDM Advances

Clinician with good insight into the factors determining the patient’s response to drug therapy can use drug monitoring data. In certain conditions were a patient fails to respond to a usual therapeutic dose, measurement of plasma level can help to determine who is a true non-responder and who is a noncompliant patient. Therapeutic Drug Monitoring also provides useful information regarding individual changes in drug utilization patterns. Drug Monitoring also provides data in changes in utilization of drug as a consequence of disease process or altered physiological state. TDM is a useful adjunct in treating many patients provided the potential pit falls.

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Toxicogenomics Roles

Toxicity detection requires a means to observe (or measure) specific effects of exposures. Toxicology is focused on changes in an organism as a result of exposure to physical, chemical, or biologic agents. Such changes range from reversible effects like transient skin reactions and chronic diseases like as cancer, or to the extreme end point of death. Studies of whole-animal toxicology may range from single-dose acute to chronic lifetime exposures and they include determination of end points like clinical signs of toxicity, organ and body weight changes, clinical chemistry, and histopathologic responses. Predictive toxicology means the study of how toxic effects noted in humans or model systems can be used to assess risk, predict pathogenesis and prevent human disease. Predictive toxicology not only includes risk assessment but also the practical facilitation of decision making with scientific information.

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OMICS Technologies

Toxicogenomic technologies comprises of several different technology platforms which are used for analysis of genomes, proteins, metabolites and transcripts. Genomic technologies includes genome sequencing technologies to derive DNA sequences from genes and other parts of DNA and genotype analysis, to detect sequence variations between individual genes. Transcriptomic technologies measures mRNA expression in a highly parallel assay system, mostly using microarrays. Proteomics studies is the collections of proteins in living systems as the same proteins may be present in multiple modified and variant forms. Metabolomics means the study of small-molecule components of biologic systems.As metabolites reflect the activities of proteins, RNAs and the genes that encode them. Metabolomics provides the functional assessment of diseases and chemical and drug toxicity. Bioinformatics focuses on applying advanced computational techniques to the biologic data and to perform all the genomic technologies.

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Adverse Outcome Pathways

An adverse outcome pathway (AOP) is a conceptual framework that organizes existing knowledge concerning biologically plausible, and empirically supported, links between molecular-level perturbation of a biological system and an adverse outcomes at a level of biological organization of regulatory relevance. Systematic organization of information into AOP frameworks has potential to improve regulatory decision-making through greater integration and more meaningful use of mechanistic data. However, for the scientific community to collectively develop a useful AOP knowledgebase that encompasses toxicological contexts of concern to human health and ecological risk assessment, it is critical that AOPs be developed in accordance with a consistent set of core principles. Based on the experiences and scientific discourse among a group of AOP practitioners, we propose a set of five fundamental principles that guide AOP development: (1) AOPs are not chemical specific; (2) AOPs are modular and composed of reusable components-notably key events (KEs) and key event relationships (KERs); (3) an individual AOP, composed of a single sequence of KEs and KERs, is a pragmatic unit of AOP development and evaluation; (4) networks composed of multiple AOPs that share common KEs and KERs are likely to be the functional unit of prediction for most real-world scenarios; and (5) AOPs are living documents that will evolve over time as new knowledge is generated. The goal of the present article was to introduce some strategies for AOP development and detail the rationale behind these 5 key principles. Consideration of these principles addresses many of the current uncertainties regarding the AOP framework and its application and is intended to foster greater consistency in adverse reactions development.

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Environmental Toxicogenomics

Environmental genomics has revolutionized the study of adverse effects of environmental toxicants. It gives an efficient and high-throughput means to understand the mechanisms of action, risk assessment and to identify and understand basic pathogenic mechanisms that are crucial in disease progression, predicting toxicity and to more precisely phenotype disease subtypes. Environmental genomics in a toxicant exposure model is a crucial tool in biological response marker or biomarker discovery.

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Comparative Toxicogenomics

Comparative Toxicogenomics is a research tool that curates scientific data describing relationships between chemicals, drugs and genes, proteins, GO annotations, pathways, diseases, taxa, phenotypes, and interaction modules. Comparative Toxicogenomics gives information on Gene-disease associations, Chemical-disease associations, Chemical-gene interactions and Chemical-phenotype associations.

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Toxicogenomics Challenges

Toxicogenomics challenges include Gene annotation, Cross-species extrapolation, Technical standards for evolving platforms, Standards for data sharing, Biomarker qualification and Translation of assays for regulatory purposes.

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Toxicogenomics Applications

As toxicogenomics continues to move forward, it will likely seem at times as if progression is standing still and at other times advancing quickly. In order to advance, key milestones will require coordination across fields and disciplines, so progress is likely to be incremental. Within the next 5 years, it is likely that toxicogenomics will move slowly forward. Biologists will continue to impact the field of informatics, and what constitutes a pathway will be better defined and begun to be standardized universally. In addition, the work of discovery and validation of prodromal biomarkers for a variety of toxicities and diseases will continue to evolve. The advance in technology will no doubt come with reduced cost per sample for analysis and will enable simultaneous probing of genetic, genomic, proteomic and metabolomic events. In the regulatory environment, toxicogenomics biomarker data will routinely be used to better inform the risk assessment from in vitro and in vivo test systems. The acceptance of modified test systems will eventually lead to an impact that minimizes animal testing and allows efficient modelling from human in vitro–based assays and ultra lowdose testing of human subjects to extrapolate and inform toxicity predictions. These models will eventually lead way to predictive in silico models that can help reduce use of animals and cost of experiments conducted to assess hazard and risk.

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