New York City, NY, United States
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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News Article | May 10, 2017
Site: globenewswire.com

NEW YORK, May 10, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced the appointment of Dr. Thomas Lodise, Dr. Thomas Holland and Dr. William O’Riordan to the Clinical Advisory Board. The three new advisory board members are medical and scientific leaders in their fields: Thomas Lodise, Pharm.D., Ph.D. is a Professor at Albany College of Pharmacy and Health Sciences, Albany, New York and an infectious diseases clinical pharmacy specialist at the Stratton VA Medical Center, Albany, New York. His specific research objectives are to develop “personalized” patient care strategies that improve outcomes; reduce the likelihood of drug-induced toxicities; minimize the emergence of antibiotic resistant infections; and reduce healthcare costs.  He has published over 110 peer-reviewed articles and is an editorial board member for Antimicrobial Agents and Chemotherapy, Pharmacotherapy, and Diagnostic Microbiology and Infectious Diseases.  He is the current chair of the PK Special Emphasis Panel for the Antibacterial Resistance Leadership Group (ARLG), an initiative funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Thomas L. Holland, M.D., MSc-GH is an Assistant Professor at Duke University School of Medicine. Board certified in infectious disease, Dr. Holland has held a number of clinical positions at Duke University School of Medicine and is currently Assistant Professor in the Department of Infectious Diseases. With over 30 publications, Dr. Holland is an expert in antibacterial resistance with a focus on Gram-positive bacteria and is a member of ARLG. William D. O’Riordan, M.D. is the founder and CEO of eStudy Sites, one of the pre-eminent networks of clinical trial sites in the U.S. He is certified with the American Board of Emergency Medicine and is the lead investigator at the Chula Vista Research Site in California.  Dr. O’Riordan has held a number of clinical positions at the UCLA (University of California, Los Angeles) Medical Center and works at the Department of Emergency Medicine at the Sharp Chula Vista Medical Center. As a clinical trial investigator at the eStudy Site at the Chula Vista Research Site, he has overseen numerous clinical trials with antibacterial agents at all stages of clinical development. Dr. David Huang, CMO of Motif Bio, commented: “We are delighted to welcome these three outstanding scientific leaders to our Clinical Advisory Board. Each of them brings specific expertise that will be invaluable as we develop and prepare to commercialize iclaprim for patients with serious and life-threatening infections.” Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


News Article | May 10, 2017
Site: globenewswire.com

NEW YORK, May 10, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced the appointment of Dr. Thomas Lodise, Dr. Thomas Holland and Dr. William O’Riordan to the Clinical Advisory Board. The three new advisory board members are medical and scientific leaders in their fields: Thomas Lodise, Pharm.D., Ph.D. is a Professor at Albany College of Pharmacy and Health Sciences, Albany, New York and an infectious diseases clinical pharmacy specialist at the Stratton VA Medical Center, Albany, New York. His specific research objectives are to develop “personalized” patient care strategies that improve outcomes; reduce the likelihood of drug-induced toxicities; minimize the emergence of antibiotic resistant infections; and reduce healthcare costs.  He has published over 110 peer-reviewed articles and is an editorial board member for Antimicrobial Agents and Chemotherapy, Pharmacotherapy, and Diagnostic Microbiology and Infectious Diseases.  He is the current chair of the PK Special Emphasis Panel for the Antibacterial Resistance Leadership Group (ARLG), an initiative funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Thomas L. Holland, M.D., MSc-GH is an Assistant Professor at Duke University School of Medicine. Board certified in infectious disease, Dr. Holland has held a number of clinical positions at Duke University School of Medicine and is currently Assistant Professor in the Department of Infectious Diseases. With over 30 publications, Dr. Holland is an expert in antibacterial resistance with a focus on Gram-positive bacteria and is a member of ARLG. William D. O’Riordan, M.D. is the founder and CEO of eStudy Sites, one of the pre-eminent networks of clinical trial sites in the U.S. He is certified with the American Board of Emergency Medicine and is the lead investigator at the Chula Vista Research Site in California.  Dr. O’Riordan has held a number of clinical positions at the UCLA (University of California, Los Angeles) Medical Center and works at the Department of Emergency Medicine at the Sharp Chula Vista Medical Center. As a clinical trial investigator at the eStudy Site at the Chula Vista Research Site, he has overseen numerous clinical trials with antibacterial agents at all stages of clinical development. Dr. David Huang, CMO of Motif Bio, commented: “We are delighted to welcome these three outstanding scientific leaders to our Clinical Advisory Board. Each of them brings specific expertise that will be invaluable as we develop and prepare to commercialize iclaprim for patients with serious and life-threatening infections.” Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


News Article | May 10, 2017
Site: globenewswire.com

NEW YORK, May 10, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced the appointment of Dr. Thomas Lodise, Dr. Thomas Holland and Dr. William O’Riordan to the Clinical Advisory Board. The three new advisory board members are medical and scientific leaders in their fields: Thomas Lodise, Pharm.D., Ph.D. is a Professor at Albany College of Pharmacy and Health Sciences, Albany, New York and an infectious diseases clinical pharmacy specialist at the Stratton VA Medical Center, Albany, New York. His specific research objectives are to develop “personalized” patient care strategies that improve outcomes; reduce the likelihood of drug-induced toxicities; minimize the emergence of antibiotic resistant infections; and reduce healthcare costs.  He has published over 110 peer-reviewed articles and is an editorial board member for Antimicrobial Agents and Chemotherapy, Pharmacotherapy, and Diagnostic Microbiology and Infectious Diseases.  He is the current chair of the PK Special Emphasis Panel for the Antibacterial Resistance Leadership Group (ARLG), an initiative funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Thomas L. Holland, M.D., MSc-GH is an Assistant Professor at Duke University School of Medicine. Board certified in infectious disease, Dr. Holland has held a number of clinical positions at Duke University School of Medicine and is currently Assistant Professor in the Department of Infectious Diseases. With over 30 publications, Dr. Holland is an expert in antibacterial resistance with a focus on Gram-positive bacteria and is a member of ARLG. William D. O’Riordan, M.D. is the founder and CEO of eStudy Sites, one of the pre-eminent networks of clinical trial sites in the U.S. He is certified with the American Board of Emergency Medicine and is the lead investigator at the Chula Vista Research Site in California.  Dr. O’Riordan has held a number of clinical positions at the UCLA (University of California, Los Angeles) Medical Center and works at the Department of Emergency Medicine at the Sharp Chula Vista Medical Center. As a clinical trial investigator at the eStudy Site at the Chula Vista Research Site, he has overseen numerous clinical trials with antibacterial agents at all stages of clinical development. Dr. David Huang, CMO of Motif Bio, commented: “We are delighted to welcome these three outstanding scientific leaders to our Clinical Advisory Board. Each of them brings specific expertise that will be invaluable as we develop and prepare to commercialize iclaprim for patients with serious and life-threatening infections.” Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


News Article | May 10, 2017
Site: globenewswire.com

NEW YORK, May 10, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced the appointment of Dr. Thomas Lodise, Dr. Thomas Holland and Dr. William O’Riordan to the Clinical Advisory Board. The three new advisory board members are medical and scientific leaders in their fields: Thomas Lodise, Pharm.D., Ph.D. is a Professor at Albany College of Pharmacy and Health Sciences, Albany, New York and an infectious diseases clinical pharmacy specialist at the Stratton VA Medical Center, Albany, New York. His specific research objectives are to develop “personalized” patient care strategies that improve outcomes; reduce the likelihood of drug-induced toxicities; minimize the emergence of antibiotic resistant infections; and reduce healthcare costs.  He has published over 110 peer-reviewed articles and is an editorial board member for Antimicrobial Agents and Chemotherapy, Pharmacotherapy, and Diagnostic Microbiology and Infectious Diseases.  He is the current chair of the PK Special Emphasis Panel for the Antibacterial Resistance Leadership Group (ARLG), an initiative funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Thomas L. Holland, M.D., MSc-GH is an Assistant Professor at Duke University School of Medicine. Board certified in infectious disease, Dr. Holland has held a number of clinical positions at Duke University School of Medicine and is currently Assistant Professor in the Department of Infectious Diseases. With over 30 publications, Dr. Holland is an expert in antibacterial resistance with a focus on Gram-positive bacteria and is a member of ARLG. William D. O’Riordan, M.D. is the founder and CEO of eStudy Sites, one of the pre-eminent networks of clinical trial sites in the U.S. He is certified with the American Board of Emergency Medicine and is the lead investigator at the Chula Vista Research Site in California.  Dr. O’Riordan has held a number of clinical positions at the UCLA (University of California, Los Angeles) Medical Center and works at the Department of Emergency Medicine at the Sharp Chula Vista Medical Center. As a clinical trial investigator at the eStudy Site at the Chula Vista Research Site, he has overseen numerous clinical trials with antibacterial agents at all stages of clinical development. Dr. David Huang, CMO of Motif Bio, commented: “We are delighted to welcome these three outstanding scientific leaders to our Clinical Advisory Board. Each of them brings specific expertise that will be invaluable as we develop and prepare to commercialize iclaprim for patients with serious and life-threatening infections.” Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


News Article | May 10, 2017
Site: globenewswire.com

NEW YORK, May 10, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (NASDAQ:MTFB) (AIM:MTFB.LN), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced the appointment of Dr. Thomas Lodise, Dr. Thomas Holland and Dr. William O’Riordan to the Clinical Advisory Board. The three new advisory board members are medical and scientific leaders in their fields: Thomas Lodise, Pharm.D., Ph.D. is a Professor at Albany College of Pharmacy and Health Sciences, Albany, New York and an infectious diseases clinical pharmacy specialist at the Stratton VA Medical Center, Albany, New York. His specific research objectives are to develop “personalized” patient care strategies that improve outcomes; reduce the likelihood of drug-induced toxicities; minimize the emergence of antibiotic resistant infections; and reduce healthcare costs.  He has published over 110 peer-reviewed articles and is an editorial board member for Antimicrobial Agents and Chemotherapy, Pharmacotherapy, and Diagnostic Microbiology and Infectious Diseases.  He is the current chair of the PK Special Emphasis Panel for the Antibacterial Resistance Leadership Group (ARLG), an initiative funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Thomas L. Holland, M.D., MSc-GH is an Assistant Professor at Duke University School of Medicine. Board certified in infectious disease, Dr. Holland has held a number of clinical positions at Duke University School of Medicine and is currently Assistant Professor in the Department of Infectious Diseases. With over 30 publications, Dr. Holland is an expert in antibacterial resistance with a focus on Gram-positive bacteria and is a member of ARLG. William D. O’Riordan, M.D. is the founder and CEO of eStudy Sites, one of the pre-eminent networks of clinical trial sites in the U.S. He is certified with the American Board of Emergency Medicine and is the lead investigator at the Chula Vista Research Site in California.  Dr. O’Riordan has held a number of clinical positions at the UCLA (University of California, Los Angeles) Medical Center and works at the Department of Emergency Medicine at the Sharp Chula Vista Medical Center. As a clinical trial investigator at the eStudy Site at the Chula Vista Research Site, he has overseen numerous clinical trials with antibacterial agents at all stages of clinical development. Dr. David Huang, CMO of Motif Bio, commented: “We are delighted to welcome these three outstanding scientific leaders to our Clinical Advisory Board. Each of them brings specific expertise that will be invaluable as we develop and prepare to commercialize iclaprim for patients with serious and life-threatening infections.” Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017. This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio plc’s Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.


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.


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.


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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