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1

PMI8 VALIDATION OF COST ESTIMATION TECHNIQUE FOR HOSPITALIZATIONS FOR USE IN MULTINATIONAL ECONOMIC EVALUATIONS

SD Reed, JY Friedman, A Gnanasakthy, KA Schulman

Journal:

Value in Health

Year:

2002

Language:

english

File:

PDF, 78 KB

english, 2002

2

THE IMPACT OF HOSPITAL COSTING METHODS ON STATISTICAL POWER IN MULTINATIONAL CLINICAL TRIALS

Sd Reed, Jy Friedman, Jh Malenbaum, A Gnanasakthy, Ka Schulman

Journal:

Value in Health

Year:

2001

Language:

english

File:

PDF, 248 KB

english, 2001

3

ESTIMATING INCREMENTAL COSTS FOR ADDITIONAL HOSPITAL DAYS

Jy Friedman, Sd Reed, A Gnanasakthy, Ka Schulman

Journal:

Value in Health

Year:

2001

Language:

english

File:

PDF, 999 KB

english, 2001

4

Single-blind, placebo-controlled multicenter trial of vigabatrin in the treatment of epilepsy

The Italian Study Group on Vigabatrin, C. Loeb, A. Iudice, E. Percucca, A. Gnanasakthy, F. Angeleri, O. Scarpino, G. Avanzini, D. Binelli, A. Baruzzi, G. Procaccianti, B. Bergamasco, C. Bianco, R. Can

Journal:

Neurological Sciences

Year:

1992

Language:

english

File:

PDF, 549 KB

english, 1992

5

Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier

Dennis A. Revicki, Ari Gnanasakthy, Kevin Weinfurt

Journal:

Quality of Life Research

Year:

2007

Language:

english

File:

PDF, 146 KB

english, 2007

6

A cluster analysis of the effects of storage mites as allergens in relation to certain occupations and living conditions

M. AGHA, A. GNANASAKTHY

Journal:

Clinical & Experimental Allergy

Year:

1981

Language:

english

File:

PDF, 312 KB

english, 1981

7

Using Multiple Anchor- and Distribution-Based Estimates to Evaluate Clinically Meaningful Change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) Instrument

Kathleen J. Yost, Mark V. Sorensen, Elizabeth A. Hahn, G. Alastair Glendenning, Ari Gnanasakthy, David Cella

Journal:

Value in Health

Year:

2005

Language:

english

File:

PDF, 118 KB

english, 2005

8

Efficacy and Tolerability of Vigabatrin in Children with Refractory Partial Seizures: A Single-Blind Dose-Increasing Study

Bernardo Dalla Bernardina, E. Fontana, F. Vigevano, L. Fusco, D. Torelli, D. Galeone, D. Buti, C. Cianchetti, A. Gnanasakthy, A. Iudice

Journal:

Year:

1995

Language:

english

File:

PDF, 492 KB

english, 1995

9

Patient reported outcomes: looking beyond the label claim

Lynda C Doward, Ari Gnanasakthy, Mary G Baker

Journal:

Health and Quality of Life Outcomes

Year:

2010

Language:

english

File:

PDF, 549 KB

english, 2010

10

Some effects of different rearing systems on health, cleanliness and injury in calves

A.J.F. Webster, C. Saville, B.M. Church, A. Gnanasakthy, R. Moss

Journal:

British Veterinary Journal

Year:

1985

Language:

english

File:

PDF, 580 KB

english, 1985

11

The effect of different rearing systems on the development of calf behaviour

A.J.F. Webster, C. Saville, B.M. Church, A. Gnanasakthy, R. Moss

Journal:

British Veterinary Journal

Year:

1985

Language:

english

File:

PDF, 778 KB

english, 1985

12

Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT)

Shelby D Reed, Joëlle Y Friedman, Eric J Velazquez, Ari Gnanasakthy, Robert M Califf, Kevin A Schulman

Journal:

American Heart Journal

Year:

2004

Language:

english

File:

PDF, 159 KB

english, 2004

13

Conducting economic evaluations alongside multinational clinical trials: Toward a research consensus

Shelby D. Reed, Kevin J. Anstrom, Ameet Bakhai, Andrew H. Briggs, Robert M. Califf, David J. Cohen, Michael F. Drummond, Henry A. Glick, Ari Gnanasakthy, Mark A. Hlatky, Bernie J. O'Brien, Frank M. To

Journal:

American Heart Journal

Year:

2005

Language:

english

File:

PDF, 225 KB

english, 2005

14

Capturing patients' perspectives of treatment in clinical trials/drug development

Asha Hareendran, Ari Gnanasakthy, Randall Winnette, Dennis Revicki

Journal:

Contemporary Clinical Trials

Year:

2012

Language:

english

File:

PDF, 179 KB

english, 2012

15

Savings in the cost of caring for patients with Alzheimer's disease in Canada: An analysis of treatment with rivastigmine

A. Brett Hauber, Ari Gnanasakthy, Josephine A. Mauskopf

Journal:

Clinical Therapeutics

Year:

2000

Language:

english

File:

PDF, 960 KB

english, 2000

16

Using patient- and clinician-rated anchors to evaluate change on the functional assessment of cancer therapy—biologic response modifiers

ElizabethA. Hahn, Ari Gnanasakthy, G.Alastair Glendenning, MarkV. Sorensen, Linda Odom, David Cella

Journal:

Clinical Therapeutics

Year:

2002

Language:

english

File:

PDF, 147 KB

english, 2002

17

PMC31 CONTROLLING MEASUREMENT ERROR OF PATIENT-REPORTED-OUTCOMES DURING THE IMPLEMENTATION STAGE OF CLINICAL TRIALS

Journal:

Value in Health

Year:

2008

Language:

english

File:

PDF, 71 KB

english, 2008

18

PMC21 PATIENT-REPORTED OUTCOMES IN PRODUCT DEVELOPMENT GUIDANCE

M Mordin, S Lewis, A Gnanasakthy, C Demuro-Mercon, K Copley-Merriman, S Fehnel

Journal:

Value in Health

Year:

2010

Language:

english

File:

PDF, 96 KB

english, 2010

19

PMC31 THE ROLE OF THE PATIENT VOICE IN HEALTH TECHNOLOGY ASSESSMENT

A Gnanasakthy, C DeMuro, M Mordin, K Copley-Merriman, J Mauskopf

Journal:

Value in Health

Year:

2010

Language:

english

File:

PDF, 68 KB

english, 2010

20

PMC55 IMPACT OF THE FDA DRAFT GUIDANCE ON PATIENT REPORTED OUTCOMES (PRO) LABEL CLAIMS FOR APPROVED DRUG PRODUCTS IN THE US: HAS IT MADE A DIFFERENCE?

M Mordin, M Clark, C Siersma, K Copley-Merriman, A Gnanasakthy

Journal:

Value in Health

Year:

2009

Language:

english

File:

PDF, 87 KB

english, 2009

21

ND2: POTENTIAL SAVINGS IN THE COST OF TREATING ALZHEIMER'S DISEASE: PATIENT TREATMENT WITH RIVASTIGMINE

AB Hauber, A Gnanasakthy, EH Snyder, A Richter, JA Mauskopf

Journal:

Value in Health

Year:

1999

Language:

english

File:

PDF, 50 KB

english, 1999

22

The effects of soil-applied granular pesticides on the establishment and yield of sugar beet in commercial fields

G.L. Maughan, D.A. Cooke, A. Gnanasakthy

Journal:

Crop Protection

Year:

1984

Language:

english

File:

PDF, 756 KB

english, 1984

23

PHP96 REASONS FOR REJECTION OF PRO LABEL CLAIMS: AN ANALYSIS BASED ON A REVIEW OF PRO USE AMONG NEW MOLECULAR ENTITIES AND BIOLOGIC LICENSE APPLICATIONS 2006-2010

C. DeMuro, M. Clark, M. Mordin, E. Evans, K. Copley-Merriman, S.E. Fehnel, A. Gnanasakthy

Journal:

Value in Health

Year:

2011

Language:

english

File:

PDF, 55 KB

english, 2011

24

PHP97 PRO LABEL CLAIMS: AN ANALYSIS BASED ON A REVIEW OF PROS AMONG NEW MOLECULAR ENTITIES AND BIOLOGIC LICENSE APPLICATIONS 2006-2010

M. Mordin, M. Clark, C. DeMuro, E. Evans, K. Copley-Merriman, S. Fehnel, A. Gnanasakthy

Journal:

Value in Health

Year:

2011

Language:

english

File:

PDF, 55 KB

english, 2011

25

A Review of Patient-Reported Outcome Labels in the United States: 2006 to 2010

Ari Gnanasakthy, Margaret Mordin, Marci Clark, Carla DeMuro, Sheri Fehnel, Catherine Copley-Merriman

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 329 KB

english, 2012

26

Reasons for Rejection of Patient-Reported Outcome Label Claims: A Compilation Based on a Review of Patient-Reported Outcome Use among New Molecular Entities and Biologic License Applications, 2006–2010

Carla DeMuro, Marci Clark, Margaret Mordin, Sheri Fehnel, Catherine Copley-Merriman, Ari Gnanasakthy

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 528 KB

english, 2012

27

PRM38 Validation of New Measures of Patients' Post-Transplant Experience in the Patientslikeme® Organ Transplant Community

M.P. Massagli, A. Gnanasakthy, P. Wicks

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 57 KB

english, 2012

28

PHP1 Incorporating the Patient's Voice Into the Assessment of Medical Devices: A Comparison of the United States and Europe

L. Doward, D. Whalley, K. Houghton, C. DeMuro, E. Evans, A. Gnanasakthy

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 68 KB

english, 2012

29

PHP182 Concordance of PRO Labeling Claims Between the FDA and EMA

A. Gnanasakthy, L. Doward, M. Clark, M. Mordin, C. Demuro

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 58 KB

english, 2012

30

PCV2 PHYSICIAN CHARACTERISTICS OF THE NAVIGATOR TRIAL PREDICT AVERAGE LENGTH OF STAY (ALOS) IN ACUTE CORONARY SYNDROME (ACS)

JY Friedman, L Curtis, A Gnanasakthy, KA Schulman

Journal:

Value in Health

Year:

2002

Language:

english

File:

PDF, 63 KB

english, 2002

31

PDB16 COST-EFFECTIVENESS OF BLOOD PRESSURE AND URINARY ALBUMIN CONTROL IN DIABETICS WITH AN ANGIOTENSIN II RECEPTOR ANTAGONIST AND A CALCIUM CHANNEL BLOCKER: PHARMACOECONOMIC ANALYSIS OF THE MARVAL TRIAL-THE CASE OF GERMANY

DG Smith, A Gnanasakthy, K Quednau

Journal:

Value in Health

Year:

2003

Language:

english

File:

PDF, 66 KB

english, 2003

32

PMC31 AT WHAT COST? A REVIEW OF DRUG ACQUISITION COST ISSUES IN MODELLED ECONOMIC EVALUATIONS.

M Wonder, M Backhouse, A Gnanasakthy

Journal:

Value in Health

Year:

2005

Language:

english

File:

PDF, 67 KB

english, 2005

33

PDB23: INVESTIGATOR AND SITE CHARACTERISTICS OF THE NAVIGATOR TRIAL

JY Friedman, L Curtis, A Gnanasakthy, D Whellan, KA Schulman

Journal:

Value in Health

Year:

2003

Language:

english

File:

PDF, 80 KB

english, 2003

34

Potential of patient-reported outcomes as nonprimary endpoints in clinical trials

Ari Gnanasakthy, Sandra Lewis, Marci Clark…

Journal:

Health and Quality of Life Outcomes

Year:

2013

Language:

english

File:

PDF, 201 KB

english, 2013

35

Quality of Life in Organ Transplant Recipients Participating in an Online Transplant Community

Wicks, Paul, Sulham, Katherine A., Gnanasakthy, Ari

Journal:

The Patient: Patient-Centered Outcomes Research

Year:

2014

Language:

english

File:

PDF, 498 KB

english, 2014

36

Correlations Between Changes in the Urticaria Activity Score (UAS7) and the Dermatology Life Quality Index (DLQI) from Baseline to 28 or 40 Weeks: Comparisons of Trajectories of Change in Patients with Chronic Spontaneous/Idiopathic Urticaria (CSU/CIU)

Stull, D.E., McBride, D., Balp, M.M., Gnanasakthy, A.

Journal:

Value in Health

Year:

2013

Language:

english

File:

PDF, 60 KB

english, 2013

37

Assessment of PRO Label Claims Granted by the FDA as Compared to the EMA (2006–2010)

DeMuro, Carla, Clark, Marci, Doward, Lynda, Evans, Emily, Mordin, Margaret, Gnanasakthy, Ari

Journal:

Value in Health

Year:

2013

Language:

english

File:

PDF, 304 KB

english, 2013

38

Influence of Patient-Reported Outcomes on HTA Reimbursement Decisions

Kulich, K., Versoza, L., Jaksa, A., Demuro-Mercon, C., Gnanasakthy, A.

Journal:

Value in Health

Year:

2013

Language:

english

File:

PDF, 58 KB

english, 2013

39

Patient-Reported Outcomes: Are They Worth It? An Examination in Pro Value Through Case Studies

DeMuro, C., Gnanasakthy, A.

Journal:

Value in Health

Year:

2013

Language:

english

File:

PDF, 60 KB

english, 2013

40

PIH49 Patient Reported Outcomes as Primary Endpoints in Confirmatory Clinical Trials

Gnanasakthy, A., Lewis, S., Clark, M., Evans, E., Mordin, M., Demuro, C.

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 56 KB

english, 2012

41

PIH53 Assessment of PRO Labels Claims Granted by the FDA as Compared to the EMA

Demuro, C., Clark, M., Coon, C., Evans, E., Mordin, M., Gnanasakthy, A.

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 56 KB

english, 2012

42

PIH54 Promotion of Patient Reported Outcomes (PRO) Label Claims Based on Non-Primary Endpoints

Gnanasakthy, A., Sadrick, A., Demuro, C., Rahul, R.

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 56 KB

english, 2012

43

Integration of patient-reported outcomes in multiregional confirmatory clinical trials

Gnanasakthy, Ari, DeMuro, Carla, Boulton, Caroline

Journal:

Contemporary Clinical Trials

Year:

2013

Language:

english

File:

PDF, 200 KB

english, 2013

44

Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds

Strand, Vibeke, Kosinski, Mark, Gnanasakthy, Ari, Mallya, Usha, Mpofu, Shephard

Journal:

Health and Quality of Life Outcomes

Year:

2014

Language:

english

File:

PDF, 209 KB

english, 2014

45

Potential Savings in the Cost of Caring for Alzheimer’s Disease

A. Brett Hauber,Ari Gnanasakthy,Edward H. Snyder,Mohan V. Bala…

Journal:

PharmacoEconomics

Year:

2000

Language:

english

File:

PDF, 130 KB

english, 2000

46

Promotion of Patient-Reported Outcome Label Claims Based on Nonprimary Endpoints

Gnanasakthy, A., Sadrick, A., Eghbal-Ahmadi, M., DeMuro, C.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2014

Language:

english

File:

PDF, 298 KB

english, 2014

47

Psychometric Evaluation Of The Psoriasis Symptom Diary Using Phase 3 Trial Data

Strober, B., Zhao, Y., Tran, M.H., Gnanasakthy, A., Nelson, L.M., McLeod, L.D., Mordin, M., Gottlieb, A., Elewski, B., Lebwohl, M.G.

Journal:

Value in Health

Year:

2014

Language:

english

File:

PDF, 64 KB

english, 2014

48

A new approach to the mathematical formulation of lactation curves

Morant, S. V., Gnanasakthy, A.

Journal:

Animal Production

Year:

1989

Language:

english

File:

PDF, 2.31 MB

english, 1989

49

The Development of Standard Economic Datasets for Use in the Economic Evaluation of Medicines

Backhouse, M. E., Gnanasakthy, A., Schulman, K. A., Akehurst, R., Glick, H.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2000

Language:

english

File:

PDF, 1.08 MB

english, 2000

50

Role of Patient-Reported Outcome Measures in the Assessment of Central Nervous System Agents

Gnanasakthy, A., DeMuro, C., Clark, M., Mordin, M., Thomas, S.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2013

Language:

english

File:

PDF, 131 KB

english, 2013