White Papers

JAN 2015

Safety, tolerability and pharmacokinetics of liposomal curcumin in healthy humans.

Storka A, Vcelar B, Klickovic U, Gouya G, Weisshaar S, Aschauer S, Bolger G, Helson L, Wolzt M. Safety, tolerability and pharmacokinetics of liposomal curcumin in healthy humans. Int J Clin Pharmacol Ther. 2015 Jan;53(1):54-65.

FEB 2014

Antiplatelet treatment for prevention of cerebrovascular events in patients with vascular diseases: a systematic review and meta-analysis.

Gouya G, Arrich J, Wolzt M, Huber K, Verheugt FWA, Gurbel PA, Pirker-Kees A., Siller-Matula J. Antiplatelet treatment for prevention of cerebrovascular events in patients with vascular diseases: a systematic review and meta-analysis. Stroke. 2014 Feb;45(2):492-503.

APR 2014

Effect of systemic high dose vitamin C therapy on forearm blood flow reactivity during endotoxemia in healthy human subjects.

Aschauer S, Gouya G, Klickovic U, Storka A, Weisshaar S, Vollbracht C, Krick B, Weiss G, Wolzt M. Effect of systemic high dose vitamin C therapy on forearm blood flow reactivity during endotoxemia in healthy human subjects. Vascul Pharmacol. 2014 Apr;61(1):25-9.

APR 2014

Retinal hemodynamic effects of antioxidant supplementation in an endotoxin-induced model of oxidative stress in humans.

Told R, Palkovits S, Schmidl D, Boltz A, Gouya G, Wolzt M, Napora KJ, Werkmeister R, Popa-Cherecheanu A, Garhfer G, Schmetterer L. Retinal hemodynamic effects of antioxidant supplementation in an endotoxin-induced model of oxidative stress in humans. Invest Ophthalmol Vis Sci. 2014 Apr 7;55(4):2220-7.

NOV 2014

Association of Nutritional Risk Index with Metabolic Biomarkers, Appetite-Regulatory Hormones, and Inflammatory Biomarkers and Outcome in Patients with Chronic Heart Failure.

Gouya G, Voithofer P, Neuhold S, Storka A, Vila G, Pacher R, Wolzt M, Huelsmann M. Association of Nutritional Risk Index with Metabolic Biomarkers, Appetite-Regulatory Hormones, and Inflammatory Biomarkers and Outcome in Patients with Chronic Heart Failure. IJCP 2014 Nov; 68(11):1293-300.

DEC 2014

Antioxidative capacity of a dietary supplement on retinal hemodynamic function in a human lipopolysaccharide (LPS) model.

Told R, Schmidl D, Palkovits S, Boltz A, Gouya G, Wolzt M, WitkowskaKJ, Popa-Cherecheanu A, Werkmeister RM, Garhfer G, Schmetterer L. Antioxidative capacity of a dietary supplement on retinal hemodynamic function in a human lipopolysaccharide (LPS) model. Invest Ophthalmol Vis Sci. 2014 Dec 18;56(1):403-11.

2014

Human Pharmacokinetics of High Dose Oral Curcumin and Its Effect on Heme Oxygenase-1 (Ho-1 Expression) in Healthy Male Subjects.

Klickovic U, Doberer D, Gouya G, Aschauer S, Weisshaar S, Storka A, Bilban M, Wolzt M. Human Pharmacokinetics of High Dose Oral Curcumin and Its Effect on Heme Oxygenase-1 (Ho-1 Expression) in Healthy Male Subjects. Biomed Res Int. 2014;2014:458592.

JUL 2013

The LPS-induced increase in circulating microparticles is not affected by vitamin C in humans.

Weisshaar S, Gouya G, Nguyen D, Kapiotis S, Wolzt M. TheLPS-induced increase in circulating microparticles is not affected by vitamin C in humans. Eur J Clin Invest. 2013 Jul;43(7):708-15.

JUL 2013

The LPS-induced increase in circulating microparticles is not affected by vitamin C in humans.

Weisshaar S, Gouya G, Nguyen D, Kapiotis S, Wolzt M. TheLPS-induced increase in circulating microparticles is not affected by vitamin C in humans. Eur J Clin Invest. 2013 Jul;43(7):708-15.

AUG 2013

Open-label, randomized study of the effect of rivaroxaban with or without acetylsalicylic acid on thrombus formation in a perfusion chamber.

Wolzt M, Gouya G, Kapiotis S, BeckaM, Mueck W, Kubitza D. Open-label, randomized study of the effect of rivaroxaban with or without acetylsalicylic acid on thrombus formation in a perfusion chamber. Thromb Res. 2013 Aug;132(2):240-7.

SEP 2013

Effect of liposomal curcumin on red blood cells in vitro.

Storka A, Vcelar B, Klickovic U, Gouya G, Weisshaar S, Aschauer S, Helson L, Wolzt M. Effect of liposomal curcumin on red blood cells in vitro. Anticancer Res. 2013 Sep;33(9):3629-34.

SEP 2013

Personalized antiplatelet treatment after percutaneous coronary intervention: The MADONNA study.

Siller-Matula JM, Francesconi M, Dechant C, Jilma B, Maurer G, Delle-Karth G, Gouya G, Ruzicka K, Podczeck-Schweighofer A, Christ G. Personalized antiplatelet treatment after percutaneous coronary intervention: The MADONNA study. Int J Cardiol. 2013 Sep 1;167(5):2018-23.

NOV 2013

Association of Endostatin with Mortality in Patients with Chronic Heart Failure.

Gouya G., Siller-Matula J., Fritzer-Szekeres M., Neuhold S., Storka A., Neuhofer LM, Clodi M., Hlsmann M., Pacher R., Wolzt M. Association of Endostatin with Mortality in Patients with Chronic Heart Failure. Eur J Clin Invest. 2013 Nov 5.

APR 2012

Effect on perfusion chamber thrombus size in patients with atrial fibrillation during anticoagulant treatment with oral direct thrombin inhibitors, AZD0837 or ximelagatran, or with vitamin K antagonists.

Wolzt M, Eriksson UG, Gouya G, Leuchten N, Kapiotis S, Elg M, Schtzer KM, Zetterstrand S, Holmberg M, Whlander K. Effect on perfusion chamber thrombus size in patients with atrial fibrillation during anticoagulant treatment with oral direct thrombin inhibitors, AZD0837 or ximelagatran, or with vitamin K antagonists. Thromb Res. 2012 Apr;129(4):e83-91.

MAY 2012

Human pharmacokinetics of intravenous recombinant human Cu/Zn superoxide dismutase.

Schaller G, Dittrich P, Felizeter M, Gouya G, Leuchten N, Kapiotis S, Vcelar B, Vorauer-Uhl K, Wolzt M. Human pharmacokinetics of intravenous recombinant human Cu/Zn superoxide dismutase. Int J Clin Pharmacol Ther. 2012 May 22;Volume 50(June):413-417.

NOV 2012

Comparative bioactivity of subcutaneous low molecular weight heparin in critically ill patients with normal renal function.

Gouya G, Palkovits S, Kapiotis S, Madl C, Locker G, Stella A, Wolzt M, Heinz G. Comparative bioactivity of subcutaneous low molecular weight heparin in critically ill patients with normal renal function. Brit J Clin Pharm. 2012 Nov;74(5):806-14.

MAR 2011

The association of mid-regional pro-adrenomedullin and mid-regional pro-atrial natriuretic peptide with mortality in an incident dialysis cohort.

Gouya G, Sturm G, Lamina C, Zitt E, Freisttter O, Struck J, Wolzt M, Knoll F, Lins F, Lhotta K, Neyer U, and Kronenberg F. The association of mid-regional pro-adrenomedullin and mid-regional pro-atrial natriuretic peptide with mortality in an incident dialysis cohort. PLoS One. 2011 Mar 7;6(3):e17803.

AUG 2011

Benefit of specialized clinics for the treatment of patients with heart failure.

Gouya G, Hammer A, Elhenicky M, Neuhold S, Wolzt M, Hlsmann M, Pacher R. Benefit of specialized clinics for the treatment of patients with heart failure. Eur J Intern Med. 2011 Aug;22(4):428-31.

FEB 2010

Alpha-lipoic acid improves vascular endothelial function in patients with type 2 diabetes: a placebo-controlled randomized trial.

Heinisch BB, Francesconi M, Mittermayer F, Schaller G, Gouya G, Wolzt M, Pleiner J. Alpha-lipoic acid improves vascular endothelial function in patients with type 2 diabetes: a placebo-controlled randomized trial. Eur J Clin Invest. 2010 Feb;40(2):148-54.

JAN 2010

Prognostic Value of Emerging Neurohormones in Chronic Heart Failure during Optimization of Heart Failure-Specific Therapy.

Neuhold S, Huelsmann M, Strunk G, Struck J, Adlbrecht C, Gouya G, Elhenicky M, Pacher R. Prognostic Value of Emerging Neurohormones in Chronic Heart Failure during Optimization of Heart Failure-Specific Therapy. Clin Chem. 2010 Jan;56(1):121-6.

JAN 2010

Alcohol Acutely Increases Vascular Reactivity together with Insulin Sensitivity in Type 2 Diabetic Men.

Schaller G, Kretschmer S, Gouya G, Haider DG, Mittermayer F, Riedl M, Wagner O, Pacini G, Wolzt M, Ludvik B. Alcohol Acutely Increases Vascular Reactivity together with Insulin Sensitivity in Type 2 Diabetic Men. Exp Clin Endocrinol Diabetes. 2010 Jan;118(1):57-60.

AUG 2009

Cross validation of the Multiple Electrode Aggregometry.

Siller-Matula JM, Gouya G, Wolzt M, Jilma B. Cross validation of the Multiple Electrode Aggregometry. A prospective trial in healthy volunteers. Thromb Haemost. 2009 Aug;102(2):397-403.

MAY 2009

Cross validation of aspirin effect in healthy individuals by Impact-R and PFA-100: a double blind randomized placebo controlled trial.

Gouya G, Jilma B, Niel M, Eichelberger B, Wolzt M, Panzer S. Cross validation of aspirin effect ni healthy individuals by Impact-R and PFA-100: a double blind randomized placebo controlled trial. Platelets. 2009 May;20(3):171-6.

2008

Partial reimbursement of prescription charges for generic drugs reduces costs for both health insurance and patients.

Gouya G, Reichardt B, Bidner A, Weissenfels R, Wolzt M. [Partial reimbursement of prescription charges for generic drugs reduces costs for both health insurance and patients]. Wien Klin Wochenschr. 2008;120(3-4):89-95.

2007

Survival of patients discharged after acute myocardial infarction and evidence-based drug therapy.

Gouya G, Reichardt B, Ohrenberger G, Wolzt M. Survival of patients discharged after acute myocardial infarction and evidence-based drug therapy. Eur J Epidemiol. 2007;22(3):145-9.

2007

Survival of patients discharged after acute myocardial infarction and evidence-based drug therapy.

Gouya G, Reichardt B, Ohrenberger G, Wolzt M. Survival of patients discharged after acute myocardial infarction and evidence-based drug therapy. Eur J Epidemiol. 2007;22(3):145-9.

MAR 2007

Prevalence of decreased glomerular filtration rate in patients seeking non-nephrological medical care-an evaluation using IDMS-traceable creatinine based MDRD as well as Mayo Clinic quadratic equation estimates.

Risch L, Saely CH, Neyer U, Hoefle G, Gouya G, Zerlauth M, Risch GM, Risch M, Drexel H. Prevalence of decreased glomerular filtration rate in patients seeking non-nephrological medical care-an evaluation using IDMS-traceable creatinine based MDRD as well as Mayo Clinic quadratic equation estimates. Clin Chim Acta. 2007 Mar;378(1-2):71-7.

DEC 2006

C-reactive protein is expressed and secreted by peripheral blood mononuclear cells.

Haider DG, Leuchten N, Schaller G, Gouya G, Kolodjaschna J, Schmetterer L, Kapiotis S, Wolzt M. C-reactive protein is expressed and secreted by peripheral blood mononuclear cells. Clin Exp Immunol. 2006 Dec; 146(3):533-9.

SEP 2006

Sex-specific antihypertensive drug therapy.

Phringer P, Gouya G, Reichardt B, Wolzt M. Sex-specific antihypertensive drug therapy. Wien Med Wochenschr. 2006 Sep;156(17-18):498-500.

FEB 2007

Relationship between glomerular filtration rate and the adipokines adiponectin, resistin and leptin in coronary patients with predominantly normal or mildly impaired renal function.

Risch L, Saely C, Hoefle G, Rein P, Langer P, Gouya G, Marte T, Aczel S, Drexel H. Relationship between glomerular filtration rate and the adipokines adiponectin, resistin and leptin in coronary patients with predominantly normal or mildly impaired renal function. Clin Chim Acta.2007 Feb;376(1-2):108-13.

NOV 2006

Evaluation of two fully automated novel enzyme-linked immunosorbent assays for the determination of human adiponectin in serum.

Risch L, Hoefle G, Saely C, Berchthold S, Weber M, Gouya G, Rein P, Langer P, Marte T, Aczel S, Drexel H. Evaluation of two fully automated novel enzyme-linked immunosorbent assays for the determination of human adiponectin in serum. Clin Chim Acta. 2006 Nov;373(1-2):121-6.

JUL 2003

Lower serum beta-CrossLaps in male cardiac transplant recipients treated without prednisolone.

Hfle G, Holzmller H, Gouya G, Hergan K, Hubmann M, Langer P, Drexel H. Lower serum beta-CrossLaps in male cardiac transplant recipients treated without prednisolone. Transpl Int. 2003 Jul;16(7):523-8.

OCT 2002

Adaptation of guidelines for the treatment of chronic heart failure in a specialized heart failure clinic.

Plzl G, Gouya G, Hgel H, Frick M, Ulmer H, Pachinger O. [Adaptation of guidelines for the treatment of chronic heart failure in a specialized heart failure clinic]. Wien Klin Wochenschr. 2002 Oct 31;114(19-20):833-9.

MAR 1997

The effect of systemic nitric oxide-synthase inhibition on ocular fundus pulsations in man.

Schmetterer L, Krejcy K, Kastner J, Wolzt M, Gouya G, Findl O, Lexer F, Breiteneder H, Fercher AF, Eichler HG. The effect of systemic nitric oxide-synthase inhibition on ocular fundus pulsations in man. Exp Eye Res. 1997 Mar;64(3):305-12.

DEC 1995

The effect of hyperoxia and hypercapnia on fundus pulsations in the macular and optic disc region in healthy young men.

Schmetterer L, Wolzt M, Lexer F, Alschinger C, Gouya G, Zanaschka G, Fassolt A, Eichler HG, Fercher AF. The effect of hyperoxia and hypercapnia on fundus pulsations in the macular and optic disc region in healthy young men. Exp Eye Res. 1995 Dec;61(6):685-90.

OCT 1995

Is the ECG measure RSh a promising technique for detecting class I antiarrhythmic drug action in men.

Wolzt M, Schmetterer L, Gouya G, Zanaschka G, EichlerHG. Is the ECG measure RSh a promising technique for detecting class I antiarrhythmic drug action in men J Cardiovasc Pharmacol. 1995 Oct;26(4):660-5.

Indication selection

FOUNDATIONS FOR SUCCESSFUL DRUG AND MEDICAL DEVICE DEVELOPMENT

Indication selection is the process of identifying the target disease or condition for a drug or medical device. Choosing the right indication early is one of the most important decisions a biotech or medtech company can make. It is also one that most teams get wrong.

The white paper presents a four-pillar framework: biological rationale, unmet medical need, trial feasibility, and market opportunity. Two case studies show what goes wrong when teams skip it.

Indication Selection during Drug Development

Dr. Nora Gedeon

Data Protection Officer (DPO) and Vendor Manager

Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials