scholarly journals Individualization of Dosage Regimen-an Approach Towards Improved Clinical Outcomes

2018 ◽  
Vol III (I) ◽  
pp. 16-22
Author(s):  
Syed Faaez Ul Hassan Naqvi ◽  
Tehreem Haider
Keyword(s):  
Dosage Regimen ◽  
Therapeutic Response ◽  
Therapeutic Index ◽  
Therapeutic Drug ◽  
Pathological State ◽  
Therapeutic Level ◽  
Narrow Therapeutic Index ◽  
Therapeutic Outcomes ◽  
Optimum Response ◽  
Narrow Therapeutic Index Drugs

Dosage regimen plays the most important role in obtaining the desired therapeutic outcomes. The focus perpetually is on the design of doses, their intervals and duration to acquire the optimum response. Many factors like age, gender, weight, body surface area, pathological state play a role in formulating these regimens and each factor is given importance in deciding regimen that gives the optimum response. The experiments gradually reveal the correct regimens after repeatedly being worked upon. Different parameters such as Cmax, Tmax, are calculated and estimated in order to decide by which dose and its interval the therapeutic level is maintained in the blood. Therapeutic drug monitoring is one of the most important aspects in dosage regimen where the narrow therapeutic index drugs are given and designed in such a way as to get the therapeutic response with minimized toxicity.

Applications and challenges in therapeutic drug monitoring of cancer treatment: A review

2020 ◽  
pp. 107815522097904
Author(s):  
Bushra Salman ◽  
Murtadha Al-Khabori
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Anticancer Agents ◽  
Drug Monitoring ◽  
Cancer Therapeutics ◽  
Therapeutic Index ◽  
Therapeutic Drug ◽  
Narrow Therapeutic Index ◽  
Dose Individualization ◽  
Therapeutic Outcomes ◽  
Wide Variability

Most anticancer agents show wide variability in pharmacokinetics (PK) and have a narrow therapeutic index which makes fixed dosing suboptimal. To achieve the best therapeutic outcomes with these agents, many studies have postulated using PK or therapeutic drug monitoring (TDM)-guided dosing. However, multiple factors contribute to the variability in PKs making the application of TDM in practice challenging. Also, despite the known association with clinical outcomes, standard guidelines on PK-guided dosing are lacking for most agents. Understanding the factors that contribute to PK variability and their impact is essential for dose individualization. The purpose of this review is to discuss the factors that contribute to the PK variability of anticancer agents and the challenges faced in practice when individualizing doses for certain widely used agents. Searching the literature has identified several gaps and efforts are needed to ensure better targeting of cancer therapeutics.

Deficiencies of the FDA in Evaluating Generic Formulations: Addressing Narrow Therapeutic Index Drugs

2012 ◽  
Vol 38 (4) ◽  
pp. 667-689 ◽  
Author(s):  
Michelle Hottinger ◽  
Bryan A. Liang
Keyword(s):  
Generic Drugs ◽  
Therapeutic Index ◽  
The United States ◽  
Additional Patient ◽  
Therapeutic Drug ◽  
Narrow Therapeutic Index ◽  
Safety Issues ◽  
Potential Safety ◽  
Mental Health Treatments ◽  
Narrow Therapeutic Index Drugs

Generic drugs represent a significant portion of the medical arsenal in treating disease. As copies of originator drugs, these drugs have been permitted abbreviated approval under the Hatch-Waxman Act. Yet with the current cost focus upon generic formulations, potential safety issues with generics have arisen. Although there is an established criterion of “bioequivalence” that generic formulations must demonstrate, narrow-therapeutic index drugs for sensitive clinical circumstances such as epilepsy, antiplatelet therapies, and mental health treatments may require different regulatory treatment than other generic drugs. Further, in these circumstances, differences in generic formulations may lead to adverse clinical outcomes due to less stringent bioequivalence tolerances. Yet there is no mandate for comparison between different generic formulations. Countries outside the United States advocate for narrowing tolerance ranges for these high risk health situations and the drugs for their treatment. We argue in this paper that additional patient safety matters must be taken into account for narrow therapeutic disease drugs, and regulatory bodies should emphasize greater tightness in bioequivalence before these narrow-therapeutic drug generic formulations are approved.

Nano optical and electrochemical sensors and biosensors for detection of narrow therapeutic index drugs

2021 ◽  
Vol 188 (12) ◽  
Author(s):  
Omid Heydari Shayesteh ◽  
Reza Mahjub ◽  
Akram Ranjbar ◽  
Katayoun Derakhshandeh ◽  
Mahdi Jamshidi
Keyword(s):  
Electrochemical Sensors ◽  
Therapeutic Index ◽  
Narrow Therapeutic Index ◽  
Narrow Therapeutic Index Drugs

scholarly journals Case Report: Low Hematocrit Leading to Tacrolimus Toxicity

2021 ◽  
Vol 12 ◽  
Author(s):  
Alexandre Piletta-Zanin ◽  
Aurélie De Mul ◽  
Nathalie Rock ◽  
Pierre Lescuyer ◽  
Caroline F. Samer ◽  
...  
Keyword(s):  
Whole Blood ◽  
Calcineurin Inhibitor ◽  
Plasma Concentrations ◽  
Therapeutic Index ◽  
Therapeutic Drug ◽  
Pharmacokinetic Variability ◽  
Narrow Therapeutic Index ◽  
Low Concentrations ◽  
Monitoring Procedure ◽  
Trough Concentrations

Tacrolimus is a calcineurin inhibitor characterized by a narrow therapeutic index and high intra- and inter-individual pharmacokinetic variability. Therapeutic drug monitoring in whole-blood is the standard monitoring procedure. However, tacrolimus extensively binds to erythrocytes, and tacrolimus whole-blood distribution and whole-blood trough concentrations are strongly affected by hematocrit. High whole-blood tacrolimus concentrations at low hematocrit may result in high unbound plasma concentrations and increased toxicity. We present the case of a 16-year-old girl with kidney and liver transplant in whom low concentrations of tacrolimus in the context of low hematocrit led to significant increase in the dosage of tacrolimus and participate, along with a genetic polymorphism of ABCB1, in nephrotoxicity.

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