Full Text Journal Articles by
Author Klaus Rose

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Comment on: Mumme M, et al. Tissue engineering for paediatric patients. Swiss Med Wkly. 2019.149.w20032.

Klaus Rose, Jane M Grant-Kels, David Neubauer, Lucio Fumi,

Swiss Med Wkly (Swiss medical weekly)
[2020, 150:w20239]

Cited: 0 times

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Too Many Avoidable Suicides Occur Worldwide in Young Patients.

Klaus Rose, David Neubauer, Jane M Grant-Kels,

United States (US) and European Union (EU) laws attempt to counterbalance the presumed discrimination of children in drug treatment and drug development. The US Food and Drug Administration (FDA)-rewarded pediatric studies with antidepressants triggered in 2004 an FDA black-box warning of suicidality in young patients. Fewer antidepressants were prescribed, and ... Read more >>

Rambam Maimonides Med J (Rambam Maimonides medical journal)
[2019, 10(4):]

Cited: 0 times

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Rational Use of Medicine in Children-The Conflict of Interests Story. A Review.

Klaus Rose, David Neubauer, Jane M Grant-Kels,

BACKGROUND:United States (US) and European Union (EU) legislation attempts to counterbalance the presumed discrimination in pediatric drug treatment and development. METHODS:We analyzed the history of drug development, US/EU pediatric laws, and pediatric studies required by US/EU regulatory authorities and reviewed relevant literature. RESULTS:The US and EU definitions of a child ... Read more >>

Rambam Maimonides Med J (Rambam Maimonides medical journal)
[2019, 10(3):]

Cited: 1 time

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The Challenges of Pediatric Drug Development.

Klaus Rose,

Introduction and Background:"Pediatric Drug Development" is being used to describe not the development of drugs for children, but rather the planning & conducting separate efficacy and safety (E&S) studies requested/demanded by regulatory authorities designed to produce pediatric labels. Pediatric studies required for drug approval enroll "children"; defined as <17 years ... Read more >>

Curr Ther Res Clin Exp (Current therapeutic research, clinical and experimental)
[2019, 90:128-134]

Cited: 1 time

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Are Regulatory Age Limits in Pediatric Melanoma Justified?

Klaus Rose, Philip D Walson,

Curr Ther Res Clin Exp (Current therapeutic research, clinical and experimental)
[2019, 90:113-118]

Cited: 0 times

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Questionable Industry-Sponsored Postneonatal Pediatric Studies in Slovenia.

Klaus Rose, David Neubauer, Jane M Grant-Kels,

Background:US and EU pediatric laws promote industry-sponsored pediatric studies, based on the therapeutic orphans concept that claims discrimination of children in drug treatment and drug development. Objective:We investigated the medical validity of international pediatric studies with centers in Slovenia, an EU member state, and challenge their medical utility. Methods:We analyzed ... Read more >>

Curr Ther Res Clin Exp (Current therapeutic research, clinical and experimental)
[2019, 90:86-91]

Cited: 1 time

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The Meanings of "Pediatric Drug Development".

Klaus Rose, Jane M Grant-Kels,

Pediatric drug development (PDD) became an industry goal when the Food and Drug Administration (FDA) granted patent extensions. This was later expanded to obligations for pediatric studies and to the European Medicines Agency's (EMA's) strict pediatric investigation plans (PIPs). Industry now sponsors many often international studies in young patients that ... Read more >>

Ther Innov Regul Sci (Therapeutic innovation & regulatory science)
[2019, 53(6):767-774]

Cited: 1 time

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Pediatric melanoma-The whole (conflicts of interest) story.

Klaus Rose, Jane M Grant-Kels,

Int J Womens Dermatol (International journal of women's dermatology)
[2019, 5(2):110-115]

Cited: 3 times

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Pediatric Melanoma and Drug Development.

Klaus Rose, Jane M Grant-Kels,

Importance-Pediatric melanoma occurs, albeit rarely. Should patients be treated by today's medical standards, or be subjected to medically unnecessary clinical studies? Observations-We identified international, industry-sponsored pediatric melanoma studies triggered by regulatory demands in www.clinicaltrials.gov and further pediatric melanoma studies demanded by European Union pediatric investigation plans. We retrieved related regulatory ... Read more >>

Children (Basel) (Children (Basel, Switzerland))
[2018, 5(3):]

Cited: 0 times

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Most adolescents' melanomas are conventional malignant adult-type melanomas.

Klaus Rose, Jane M Grant-Kels,

Eur. J. Cancer (European journal of cancer (Oxford, England : 1990))
[2018, 95:117-119]

Cited: 4 times

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Do Paediatric Investigation Plans (PIPs) Advance Paediatric Healthcare?

Klaus Rose, Philip D Walson,

Since 2007, new drugs need a paediatric investigation plan (PIP) for EU registration. The PIPs' justifications can be traced back to concerns expressed by Shirkey that label warnings against paediatric use made children "therapeutic orphans", and the American Academy of Pediatrics' claim that all children differ considerably from adults. US ... Read more >>

Paediatr Drugs (Paediatric drugs)
[2017, 19(6):515-522]

Cited: 5 times

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Current state and future of pediatric allergology in Europe: A road map.

Olympia Tsilochristou, Paraskevi Maggina, Zaraquiza Zolkipli, Silvia Sanchez Garcia, Pinar Uysal, Montserrat Alvaro Lozano, Marina Atanaskovic-Markovic, Astghik Baghdasaryan, Kirsten Beyer, George DuToit, Roy Gerth van Wijk, Arne Høst, Jonathan O'Hourihane, Lars Ingemann, Juho E Kivistö, Jose Manuel Lopes Dos Santos, Erik Melén, Antonella Muraro, Antonio Nieto, Giovanni Pajno, Klaus Rose, Lagos A Réthy, Cansin Sackesen, Peter Schmid Grendelmeier, Erkka Valovirta, Magnus Wickman, Philippe A Eigenmann, Ulrich Wahn, Lauri-Ann van der Poel,

The history of pediatric allergology (PA) in Europe is relatively youthful, dating back to 1984, when a small group of pediatricians founded the European Working Group on Pediatric Allergy and Immunology-later giving rise to ESPACI (European Society on Pediatric Allergology and Clinical Immunology). In 1990, the first dedicated journal, Pediatric ... Read more >>

Pediatr Allergy Immunol (Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology)
[2018, 29(1):9-17]

Cited: 1 time

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The Effect of Regulation on Pediatric Psoriasis Drug Approvals: The Challenge of the European Union Pediatric Investigation Plans.

Klaus Rose, Rudolf Happle,

Pediatr Dermatol (Pediatric dermatology)
[2017, 34(3):e154-e159]

Cited: 6 times

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New Drugs for Rare Diseases in Children.

Klaus Rose,

PURPOSE:United States (US) Pediatric Legislation (PL) was introduced in 1997 to improve children's health. The European Union PL (EUPL) has been in force since 2007. Both PLs facilitate additional pediatric research on primarily adult drugs. The EUPL declares that the forces of the market are not sufficient for children. Without ... Read more >>

Clin Ther (Clinical therapeutics)
[2017, 39(2):246-252]

Cited: 3 times

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Do the European Medicines Agency Decisions Hurt Pediatric Melanoma Patients?

Klaus Rose, Philip D Walson,

PURPOSE:US pediatric legislation was introduced in 1997 and was followed by European Union pediatric legislation that, since 2007, requires a European Medicines Agency (EMA)-approved pediatric investigation plan (PIP) for registration of new medicines unless they are PIP exempted. In 2008, the EMA decided that enough adolescent patients with melanoma existed ... Read more >>

Clin Ther (Clinical therapeutics)
[2017, 39(2):253-265]

Cited: 8 times

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Children with multiple sclerosis should not become therapeutic hostages.

Klaus Rose, Thomas Müller,

Both the United States (US) Food and Drug Administration (FDA) and the European Union (EU) European Medicines Agency (EMA) order pediatric clinical trials as a condition for approval of new compounds. We evaluate clinical value and likelihood of sufficient recruitment for pediatric multiple sclerosis (pMS) studies and discuss US and ... Read more >>

Ther Adv Neurol Disord (Therapeutic advances in neurological disorders)
[2016, 9(5):389-395]

Cited: 12 times

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Pediatric investigation plans for specific immunotherapy: Questionable contributions to childhood health.

Klaus Rose, Matthias Volkmar Kopp,

Allergen-specific immunotherapy (SIT) is the only disease-modifying treatment for children, adolescents, and adults with allergic diseases. The EU has a combined system of national and EU-wide marketing authorization for all medicines. Germany introduced a new therapy allergen ordinance in 2008. Allergen products manufacturers had to apply for marketing authorization application ... Read more >>

Pediatr Allergy Immunol (Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology)
[2015, 26(8):695-701]

Cited: 11 times

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The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia.

Klaus Rose, Philip D Walson,

BACKGROUND:Although the diagnosis of childhood leukemia is no longer a death sentence, too many patients still die, more with acute myeloid leukemia than with acute lymphoblastic leukemia. The European Union pediatric legislation was introduced to improve pharmaceutical treatment of children, but some question whether the European Medicines Agency (EMA) approach ... Read more >>

Risk Manag Healthc Policy (Risk management and healthcare policy)
[2015, 8:185-205]

Cited: 7 times

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A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials.

Klaus Rose, Hans Kummer,

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from ... Read more >>

Children (Basel) (Children (Basel, Switzerland))
[2015, 2(2):198-210]

Cited: 8 times

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Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency.

Klaus Rose, Michael G Spigarelli,

The European Pediatric Pharmaceutical Legislation wants children to benefit more from pharmaceutical progress. In rare diseases, concerns have been raised that this legislation might damage research and stymie drug development. We discuss the role of the European Medicines Agency (EMA) and its Pediatric Committee (PDCO) in the development of ivacaftor, ... Read more >>

Children (Basel) (Children (Basel, Switzerland))
[2015, 2(1):108-130]

Cited: 1 time

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Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee--adolescents' melanoma as a paradigm.

Klaus Rose, Stephen Senn,

The European Medicines Agency (EMA) website lists all diseases that officially exist in adults only. The class waiver for juvenile melanoma was revoked in 2008 referring to US SEER statistics. This statistical justification is misleading. Melanoma in adolescents is much rarer than claimed by EMA/Paediatric Committee; < 1 ∕ 4 of adolescents with melanoma ... Read more >>

Pharm Stat (Pharmaceutical statistics)
[2014, 13(4):211-213]

Cited: 10 times

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European Union pediatric legislation jeopardizes worldwide, timely future advances in the care of children with cancer.

Klaus Rose,

BACKGROUND: Diagnosis of childhood cancer is no longer an automatic death sentence, but it has not lost all of its horror. Drugs, surgery, radiation, and clinical trials have advanced our capacity to handle these cancers, but pediatric cancers still face challenges. Pediatric pharmaceutical legislation was introduced in the United States ... Read more >>

Clin Ther (Clinical therapeutics)
[2014, 36(2):163-177]

Cited: 14 times

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The value of juvenile animal studies: a pediatric clinical perspective.

Klaus Rose,

With the emphasis of US American and European legislators on consideration of children in the drug development process regulatory authorities ask increasingly for additional non-clinical data to elucidate the safety of a given drug in development in future pediatric use. Juvenile animal studies are increasingly requested. These requests should never ... Read more >>

Birth Defects Res. B Dev. Reprod. Toxicol. (Birth defects research. Part B, Developmental and reproductive toxicology)
[2011, 92(4):252-253]

Cited: 1 time

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Development of paediatric medicines: concepts and principles.

Klaus Rose, Oscar Della Pasqua,

The term "off-label use of drugs in children" is common to current medical practice. A look into the historical context helps to elucidate the framework for the use of medicines in children. Proper drug labels are relatively new in history. They emerged half a century ago when U.S. legislation forced ... Read more >>

Handb Exp Pharmacol (Handbook of experimental pharmacology)
[2011, 205:111-124]

Cited: 6 times

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Challenges in pediatric drug development: a pharmaceutical industry perspective.

Klaus Rose,

A paradigm change is taking place from protecting children against clinical research to protecting them through research. It is based on a better scientific understanding of the child's physiology, on the increasing potential of biomedical interventions, and on an evolving conviction of children's right to benefit from scientific and pharmaceutical ... Read more >>

Paediatr Drugs (Paediatric drugs)
[2009, 11(1):57-59]

Cited: 6 times

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