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From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients

Clinical pharmacology and therapeutics, 2015-03, Vol.97 (3), p.234-246

2015

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Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval

Clinical pharmacology and therapeutics, 2012-03, Vol.91 (3), p.426-437

2012

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"Threshold-crossing": A Useful Way to Establish the Counterfactual in Clinical Trials?

Clinical pharmacology and therapeutics, 2016-12, Vol.100 (6), p.699-712

2016

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Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators

Clinical pharmacology and therapeutics, 2016-05, Vol.99 (5), p.548-554

2016

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Asthma severity and medical resource utilisation

The European respiratory journal, 2004-05, Vol.23 (5), p.723-729

2004

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Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making

Clinical pharmacology and therapeutics, 2016-12, Vol.100 (6), p.633-646

2016

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Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan

Clinical pharmacology and therapeutics, 2016-12, Vol.100 (6), p.626-632

2016

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Accelerated Access to Innovative Medicines for Patients in Need

Clinical pharmacology and therapeutics, 2014-11, Vol.96 (5), p.559-571

2014

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A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials

Clinical pharmacology and therapeutics, 2014-02, Vol.95 (2), p.147-153

2014

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The impact of delayed chemotherapy-induced nausea and vomiting on patients, health resource utilization and costs in German cancer centers

Annals of oncology, 2004-03, Vol.15 (3), p.526-536

2004

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Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions

Clinical pharmacology and therapeutics, 2015-11, Vol.98 (5), p.522-533

2015

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A randomized, double-blind, placebo controlled study on analgesic effects of botulinum toxin A

Neurology, 2003-10, Vol.61 (7), p.940

2003

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Advancing the Science of Medicines Regulation: The Role of the 21st-Century Medicines Regulator

Clinical pharmacology and therapeutics, 2012-10, Vol.92 (4), p.486-493

2012

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Effect of dorzolamide and timolol on ocular blood flow in patients with primary open angle glaucoma and ocular hypertension

British journal of ophthalmology, 2005-10, Vol.89 (10), p.1293-1297

2005

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European Perspective on Risk Management and Drug Safety

Clinical pharmacology and therapeutics, 2011-05, Vol.89 (5), p.650-654

2011

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Colonic spread and serum pharmacokinetics of budesonide foam in patients with mildly to moderately active ulcerative colitis

Alimentary pharmacology & therapeutics, 2005-09, Vol.22 (5), p.463-470

2005

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Heparin blunts endotoxin-induced coagulation activation

Circulation (New York, N.Y.), 1999-12, Vol.100 (25), p.2485-2490

1999

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Gastrointestinal transit and 5‐ASA release from a new mesalazine extended‐release formulation

Alimentary pharmacology & therapeutics, 2003-02, Vol.17 (3), p.395-402

2003

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Effects of erythropoietin on platelet reactivity and thrombopoiesis in humans

Blood, 2000-05, Vol.95 (9), p.2983-2989

2000

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bcl-2 antisense therapy chemosensitizes human melanoma in SCID mice

Nature medicine, 1998-02, Vol.4 (2), p.232-234

1998

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Clonidine added to bupivacaine enhances and prolongs analgesia after brachial plexus block via a local mechanism in healthy volunteers

European journal of anaesthesiology, 2004-03, Vol.21 (3), p.198-204

2004

Volltextzugriff (PDF)

5‐aminosalicylic acid release from a new controlled‐release mesalazine formulation during gastrointestinal transit in healthy volunteers

Alimentary pharmacology & therapeutics, 2006-01, Vol.23 (1), p.137-144

2006

Volltextzugriff (PDF)

Mucosal tolerance as therapy of type I allergy: intranasal application of recombinant Bet v 1, the major birch pollen allergen, leads to the suppression of allergic immune responses and airway inflammation in sensitized mice

Clinical and experimental allergy, 2002-01, Vol.32 (1), p.30-36

2002

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Evaluation of the Zeiss retinal vessel analyser

British journal of ophthalmology, 2000-11, Vol.84 (11), p.1285-1290

2000

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Regulation of adhesion molecules during human endotoxemia : No acute effects of aspirin

American journal of respiratory and critical care medicine, 1999-03, Vol.159 (3), p.857-863

1999

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From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients

Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval

"Threshold-crossing": A Useful Way to Establish the Counterfactual in Clinical Trials?

Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators

Asthma severity and medical resource utilisation

Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making

Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan

Accelerated Access to Innovative Medicines for Patients in Need

A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials

The impact of delayed chemotherapy-induced nausea and vomiting on patients, health resource utilization and costs in German cancer centers

Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions

A randomized, double-blind, placebo controlled study on analgesic effects of botulinum toxin A

Advancing the Science of Medicines Regulation: The Role of the 21st-Century Medicines Regulator

Effect of dorzolamide and timolol on ocular blood flow in patients with primary open angle glaucoma and ocular hypertension

European Perspective on Risk Management and Drug Safety

Colonic spread and serum pharmacokinetics of budesonide foam in patients with mildly to moderately active ulcerative colitis

Heparin blunts endotoxin-induced coagulation activation

Gastrointestinal transit and 5‐ASA release from a new mesalazine extended‐release formulation

Effects of erythropoietin on platelet reactivity and thrombopoiesis in humans

bcl-2 antisense therapy chemosensitizes human melanoma in SCID mice

Clonidine added to bupivacaine enhances and prolongs analgesia after brachial plexus block via a local mechanism in healthy volunteers

5‐aminosalicylic acid release from a new controlled‐release mesalazine formulation during gastrointestinal transit in healthy volunteers

Mucosal tolerance as therapy of type I allergy: intranasal application of recombinant Bet v 1, the major birch pollen allergen, leads to the suppression of allergic immune responses and airway inflammation in sensitized mice

Evaluation of the Zeiss retinal vessel analyser

Regulation of adhesion molecules during human endotoxemia : No acute effects of aspirin

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