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New York City, NY, United States

Albany College of Pharmacy and Health science is a private and independent college whose mission is to graduate the best health care minds in the world. The college has campuses in Albany, New York and Colchester, Vermont. Wikipedia.


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Pai M.P.,Albany College of Pharmacy and Health Sciences
Pharmacotherapy | Year: 2012

The average weight of adults in the United States has increased by 25 pounds (11 kg) over the past 50 years, with a marginal change in height. Drugs are generally dosed according to one of three approaches: fixed dosing, weight-based dosing, or body surface area-based dosing. Dosing based on body weight or body surface area assumes that drug pharmacokinetic parameters increase in proportion with increasing body size. In contrast, dosing drugs on a fixed basis assumes that drug pharmacokinetic parameters do not increase with body size. Unfortunately, early stages of clinical drug development tend to include adults within a narrow range of body size. This study population does not reflect the current U.S. population distribution and does not permit evaluation of the correct relationship between body size and drug clearance. As a consequence, a weight-based or body surface area-based dosing regimen defined during drug development may not be applicable to U.S. patient populations. These dosing strategies are more likely to result in drug overexposure (weight-based approach) or underexposure (body surface area-based approach) among obese patients. Alternate weight descriptors such as ideal body weight, adjusted body weight, fat-free weight, and lean body weight are used to prevent drug overexposure with weight-based dosing, but their benefits and limitations must be understood. Reappraisal of the drug dosing paradigm is needed in this era of rising obesity; however, until drug-specific reviews can be performed, clinical studies must include patients at the extremes of the weight continuum to ensure applicable dose extrapolation for body size.


Lin H.Y.,Albany College of Pharmacy and Health Sciences
Discovery medicine | Year: 2012

The sodium/proton (Na/H) exchanger, Na,K-ATPase, and Ca2+-ATPase are membrane ion pumps whose basal activities may be regulated by local nongenomic actions of thyroid hormone and hormone analogues via a hormone receptor on plasma membrane integrin αvβ3. System A amino acid transport and the activity of P-glycoprotein (P-gp; ABCB1), a multidrug efflux pump, are also modulated by thyroid hormone and αvβ3. Where signal transduction has been studied, the presence of the hormone at the receptor is transduced by mitogen-activated protein kinase (MAPK) isoforms (ERK1/2; p38) or phosphatidylinositol 3-kinase into local actions. The existence of the cell surface receptor offers opportunities to pharmacologically modify actions of these important transport functions with nanoparticulate formulations of T4 and T3 that do not enter the cell. Such formulations may reverse complex intracellular accumulations of H+, Na+, and Ca2+ that occur in clinical settings such as ischemia. In addition, nanoparticulate tetraiodothyroacetic acid (tetrac), a thyroid hormone analogue that inhibits binding of T4 and T3 to integrin αvβ3 as well as certain other functions of the integrin, may reverse P-gp-dependent resistance to anti-cancer drugs in tumor cells.


OBJECTIVE: To summarize and evaluate the available literature assessing the efficacy and safety of exenatide once weekly for the treatment of type 2 diabetes mellitus. DATA SOURCES: PubMed (1966-January 2012) and International Pharmaceutical Abstracts (1969-January 2012) were searched using the term exenatide once weekly. Abstracts presented at the European Association for the Study of Diabetes Annual Meeting in 2011 and reference citations from publications were reviewed for inclusion. Eli Lilly and Company and Amylin Pharmaceuticals were contacted for additional unpublished information. STUDY SELECTION AND DATA EXTRACTION: All English-language articles and abstracts were evaluated for inclusion. All randomized controlled trials were included in the review. DATA SYNTHESIS: The efficacy and safety of exenatide once weekly has been evaluated as initial monotherapy and as add-on therapy to metformin, sulfonylureas, and thiazolidinediones in patients with uncontrolled type 2 diabetes for up to 3 years. Results from 6 randomized, comparator-controlled studies in over 3000 patients indicate that treatment with exenatide once weekly results in significant glycemic improvements and weight loss. Gastrointestinal adverse effects and injection site reactions are common, but rarely lead to drug discontinuation. CONCLUSIONS: Exenatide once weekly holds promise as a convenient, efficacious, and well-tolerated antihyperglycemic agent for the treatment of type 2 diabetes. Studies evaluating outcomes such as cardiovascular events or all-cause mortality with exenatide once weekly are lacking.


Bailie G.R.,Albany College of Pharmacy and Health Sciences
American Journal of Health-System Pharmacy | Year: 2012

Purpose. An analysis of reported adverse events (AEs) among patients using i.v. iron products, including the newer agent ferumoxytol, is presented. Methods. All AE reports to the Food and Drug Administration (FDA) citing iron sucrose, ferric gluconate, high- and low-molecular- weight iron dextran products, or ferumoxytol from October 2009 through June 2010 were evaluated. The rates of various classifications of reported AEs were calculated on a per-unit-sold basis and, for comparison of products supplied in different unit sizes, also in terms of 100-mg dose equivalents (DEq) of iron. Results. A total of 197 reported AEs were identified (a cumulative rate of 14.1 AEs per million units sold). The rates of all AE classifications combined ranged from 5.25 to 746 per million units sold for iron sucrose and ferumoxytol, respectively; using the other method of calculation, the rates ranged from 5.24 per million DEq (iron sucrose) to 147 per million DEq (ferumoxytol). Relative to iron sucrose and sodium ferric gluconate, ferumoxytol was associated with significantly elevated risks of death (odds ratio [OR], 475 and 156, respectively; p < 0.0001), serious nonfatal AEs (OR, 263 and 121, respectively; p < 0.0001), and all evaluated AE classifications combined (OR, 142 and 109, respectively; p < 0.05). Conclusion. Analysis of reports submitted to FDA revealed large differences among i.v. iron products in reported deaths, serious AEs, other major AEs, and other AEs. Iron sucrose and sodium ferric gluconate were associated with much lower rates of AEs per million units sold than iron dextran or ferumoxytol, which were associated with the highest rates of all reported AE classifications. Copyright © 2012, American Society of Health-System Pharmacists, Inc. All rights reserved.


Pai M.P.,Albany College of Pharmacy and Health Sciences
Journal of Antimicrobial Chemotherapy | Year: 2014

Objectives: To compare the serum and urine pharmacokinetics (PK) of intravenous tigecycline in obese class III (obese-C3) adults with those in normal weight (NW) adults. Patientsandmethods: Obese-C3 (n=8)andNW(n=4) healthyadult volunteers receivedasingle intravenousdose of 100 mg of tigecycline for 30 min. Serum (0-96 h) and urine (0-48 h) tigecycline concentrations were assayed by liquid chromatography withtandem massspectrometry. Parametric population PK systems analyseswere used to model the data and assess the effects of total body weight (TBW) on PK parameters. The area under the concentration-time curve extrapolated to infinity (AUC0-∞) was simulated to estimate the probability of AUC0-∞:MIC target attainment and cumulative fraction of response (CFR) based on wild-type MIC distributions of select pathogens. Clinicaltrials.gov: NCT01560143. Results: The median (range) age, TBWand initial body mass index were 42 (20-50) years, 121 (61-160) kg and 43.8 (20.8-53.8) kg/m2, respectively. The serum concentration-time profiles and exposures were similar in the obese-C3 and NW adults, with a mean urine recovery of 15.8% and 13.4%, respectively. The median (range) AUC0-∞was 8.19 (6.12, 11.2) and 7.50 (6.78, 9.13)mg.h/L in the obese-C3 andNWgroups, respectively. The clearance of tigecyclinewas not related to TBW. The CFRwas calculated to be<90% against Acinetobacter baumannii, Enterobacter cloacae and Klebsiella pneumoniae for an AUC0-∞:MIC target ≥6.96. Conclusions: The serum and urine PK of tigecycline is similar in obese-C3 andNWhealthy adults. A lower CFR is predicted against certain Gram-negativepathogens with the current standardtigecycline dosing regimen, irrespective of TBW. © The Author 2013. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.


Musteata F.M.,Albany College of Pharmacy and Health Sciences
TrAC - Trends in Analytical Chemistry | Year: 2013

This article reviews recent developments in in-vivo sampling and sample preparation for analysis of biological systems. The trend towards microanalytical techniques is justified by the small amount of sample that is available from some biological systems and the need to minimize interference with the system that is being studied or analyzed. Different approaches to direct in-vivo sampling and sample preparation are described, including microsampling, ultrafiltration, microextraction, microdialysis, solid-phase microextraction, biosensors, ambient mass spectrometry, spectroscopy, and microfluidic devices. © 2013 Elsevier Ltd.


Musteata F.M.,Albany College of Pharmacy and Health Sciences
Clinical Pharmacokinetics | Year: 2012

Background and Objective: In many clinical situations, measurement of the total drug concentration does not provide the needed information concerning the fraction of unbound drug in plasma, which is available for pharmacodynamic action. To address this, a 'normalized concentration' can be calculated on the basis of the observed total drug concentration and the serum protein level. Up to now, this method has only been applied to phenytoin. Several equations for calculating normalized concentrations of phenytoin have been published, many leading to different results. Regrettably, all of the equations in the current literature are based on an outdated model of drug binding to human serumalbumin and are based on the fraction of unbound drug, which is known to depend on both protein and drug concentrations. In response to the relatively new scientific evidence about drug binding to human plasma proteins, the objective of the present study is to develop a general method for calculating normalized drug concentrations in the presence of altered plasma protein binding. Methods: When several drug molecules can be bound by a protein molecule, multiple equilibria are established; these equilibria may be formulated in terms of a stoichiometric analysis or a site-oriented analysis. Both models are currently encountered in the scientific literature, sometimes without clear identification of which model is used. The present study presents the basic equations for both models and shows how the normalized concentration can be calculated on the basis of the measured drug concentration, the protein level and the binding constants. Results: The normalized concentration can be calculated for any drug, using the same simple equation regardless of the binding model and the number of binding proteins. Explicit solutions are presented for particular cases of clinical importance. The new model is validated by comparison with the Winter-Tozer equation for calculating the normalized phenytoin concentration and is found to be equivalent for concentrations close to therapeutic concentrations. In the case of phenytoin, the main advantage of the new equation is that it also works outside the linear binding range. Conclusions: A new comprehensive method for calculating normalized drug concentrations is developed, allowing drug concentrations to be interpreted correctly in cases of altered drug-protein binding. The calculations are based on binding constants and are applicable to any protein level and drug concentration, without being limited to linear binding of drugs to proteins. The new model is expected to become important in pharmacokinetic-pharmacodynamic modelling, allometric scaling and population pharmacokinetics because it provides the ability to accurately take into account physiological and pathological changes in protein binding. As a direct clinical application, the equations can be used to calculate normalized drug concentrations in patients with abnormal protein levels, such as the elderly, trauma patients and paediatric patients.


Pai M.P.,Albany College of Pharmacy and Health Sciences
Advances in Chronic Kidney Disease | Year: 2010

One-third of adult Americans are currently classified as obese. Physiologic changes associated with obesity can potentially alter the clearance of commonly used drugs. Clearance of certain drugs by the kidneys occurs primarily through glomerular filtration and tubular secretion. Obesity has been associated with glomerular hyperfiltration, whereas obesity-related effects on tubular secretion are not well characterized. Estimation of the glomerular filtration rate (GFR) is currently performed using serum creatinine using the Modification of Diet in Renal Disease (MDRD) equation. However, drug dosing guidelines are often based on creatinine clearance (CLcr) using the Cockcroft-Gault equation as a surrogate of GFR. There is a lack of consensus on the most appropriate method for estimation of GFR or CLcr in patients with obesity. The controversy relates to the use of 2 body size descriptors that confound these equations. The Cockcroft-Gault equation relies on total body weight and so overestimates GFR in patients with obesity. The MDRD equation indexes GFR based on a normalized body surface area, that is, mL/min/1.73 m2. Conversion of MDRD estimated GFR to non-normalized body surface area overestimates GFR in patients with obesity. The current review explores current approaches and controversies to estimation of GFR and CLcr among obese patients in clinical practice. The role of the alternate body size descriptor, lean body weight to estimate CLcr in obese patients is reviewed. © 2010 National Kidney Foundation, Inc.


Cabral K.P.,Albany College of Pharmacy and Health Sciences
Journal of Thrombosis and Thrombolysis | Year: 2013

Oral anticoagulation therapy is transforming with the advent of the target specific oral anticoagulants, particularly, the direct thrombin inhibitors and factor Xa inhibitors. These agents have demonstrated clinical efficacy and safety and offer several potential advantages over current standard of care therapy, warfarin. Nevertheless, the pharmacology between the newly approved oral anticoagulants differs and must be considered for appropriate management and patient selection. The pharmacodynamics and pharmacokinetics of dabigatran etexilate, rivaroxaban, apixaban and edoxaban are discussed in detail, which may translate into considerable clinical implications. © 2013 Springer Science+Business Media New York.


Patent
Ordway Research Institute Inc., Albany College of Pharmacy and Health Sciences | Date: 2013-11-13

Disclosed are methods of increasing the chemosensitivity of normal and/or chemoresistant tumor or cancer cells using thyroid hormone antagonists and/or nanoparticulate or polymeric forms thereof. Also disclosed are methods of increasing radiosensitivity of normal and/or radioresistant tumor or cancer cells using thyroid hormone antagonists and/or nanoparticulate or polymeric forms thereof.

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