ICH E 11: Clinical Investigation of Medicinal Products in the Paediatric Population

2006 ◽  
pp. 33-37 ◽  
Author(s):  
Klaus Rose ◽  
Hans Stötter
Keyword(s):  
Clinical Investigation ◽  
Paediatric Population ◽  
Medicinal Products

scholarly journals Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study

2019 ◽  
Vol 179 (3) ◽  
pp. 507-512
Author(s):  
Karen Nieber ◽  
Esther Raskopf ◽  
Johanna Möller ◽  
Olaf Kelber ◽  
Robert Fürst ◽  
...  
Keyword(s):  
Adverse Events ◽  
Common Cold ◽  
Sleep Disturbances ◽  
Skin Diseases ◽  
Herbal Medicines ◽  
Paediatric Population ◽  
Clinical Effects ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal

AbstractIn paediatrics, clinical study data are limited, especially on herbal medicinal products. To address this gap, 2063 datasets from the paediatric population were evaluated in the PhytoVIS data base. By screening for paediatric data, information on indication, gender, treatment, co-medication and tolerability were evaluated. The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety. The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events. The data shed light on a still neglected field of phyto-pharmacotherapy by giving information on the use of herbal medicines in an unselected cohort of paediatric patients. The results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.What is Known:• In Germany, about 85% of children receive one or more herbal medicinal products per year.• Despite international initiatives to promote clinical research in paediatrics, there are still many gaps of knowledge in the use of drugs in paediatrics.What is New:• The PhytoVIS project evaluated 2063 data sets from the paediatric population using herbal medicinal products.• The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety, and 84% of the patients rated the therapy as very good or good without adverse events.

scholarly journals Phytotherapy in the Management of Diabetes: A Review

2017 ◽  
Author(s):  
Paolo Governa ◽  
Giulia Baini ◽  
Vittoria Borgonetti ◽  
Giulia Cettolin ◽  
Daniela Giachetti ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Medicinal Plants ◽  
Clinical Investigation ◽  
Clinical Effectiveness ◽  
Mechanisms Of Action ◽  
Evidence Based ◽  
Medicinal Products ◽  
Key Points ◽  
Treatment Of Diabetes ◽  
Alpha Glucosidase

Phytotherapy has long been a source of medicinal products and many attempts to use herbal medicine for the treatment of diabetes has been done over the years. Several medicinal plants and their preparations demonstrated to act in key points of glucidic metabolism. The most common mechanisms of action found include the inhibition of α-glucosidase and of AGE formation, the increase of GLUT-4 and PPARs expression and the antioxidant activity.Despite the large amount of literature available, the actual clinical effectiveness of medicinal plants in controlling diabetes related symptoms is still controversial and there is a crucial need for stronger evidence-based data. In this review, an overview of the medicinal plants, which use in the management of diabetes is supported by authoritative monograph, is provided. References to some species which are currently under growing clinical investigation are also reported.

scholarly journals Phytotherapy in the Management of Diabetes: A Review

2017 ◽  
Author(s):  
Paolo Governa ◽  
Giulia Baini ◽  
Vittoria Borgonetti ◽  
Giulia Cettolin ◽  
Daniela Giachetti ◽  
...  
Keyword(s):  
Antioxidant Activity ◽  
Medicinal Plants ◽  
Clinical Investigation ◽  
Clinical Effectiveness ◽  
Mechanisms Of Action ◽  
Evidence Based ◽  
Medicinal Products ◽  
Key Points ◽  
Treatment Of Diabetes ◽  
Alpha Glucosidase

Phytotherapy has long been a source of medicinal products and many attempts to use herbal medicine for the treatment of diabetes has been done over the years. Several medicinal plants and their preparations demonstrated to act in key points of glucidic metabolism. The most common mechanisms of action found include the inhibition of α-glucosidase and of AGE formation, the increase of GLUT-4 and PPARs expression and the antioxidant activity. Despite the large amount of literature available, the actual clinical effectiveness of medicinal plants in controlling diabetes related symptoms is still controversial and there is a crucial need for stronger evidence-based data. In this review, an overview of the medicinal plants, which use in the management of diabetes is supported by authoritative monograph, is provided. References to some species which are currently under growing clinical investigation are also reported.

EMEA and the evaluation of health-related quality of life data in the drug regulatory process

2004 ◽  
Vol 20 (3) ◽  
pp. 311-324 ◽  
Author(s):  
Sotiria Papanicolaou ◽  
David Sykes ◽  
Elias Mossialos
Keyword(s):  
Quality Of Life ◽  
Clinical Investigation ◽  
Pharmaceutical Products ◽  
Regulatory Process ◽  
Health Related Quality ◽  
Medicinal Products ◽  
Hrqol Data ◽  
Related Quality ◽  
Health Related

Objectives:This study reviewed the European guidelines of the Committee for Proprietary Medicinal Products (CPMP) on how health-related quality of life (HRQOL) research should be conducted in clinical trials. Published product-level information was also reviewed to investigate the actual role of HRQOL data in the European regulatory process.Methods:All disease-specific notes for guidance and concept papers on clinical investigations, development and evaluation of human medicinal products, as well as the European Public Assessment Reports (EPAR) of all approved drugs published on the European Agency for the Evaluation of Medicinal Products (EMEA) Web site were evaluated for their HRQOL recommendations.Results:Only twenty of the fifty CPMP guidance notes for clinical investigation of pharmaceutical products in specific disease areas included a reference to HRQOL. Most of the recommendations were generic and vague, and the terminology used was inconsistent across documents. The EPAR provided nonspecific information about HRQOL and contradictory conclusions on the effect of a drug on HRQOL sometimes occurred in different documents. The criteria used by the CPMP to assess the HRQOL data could not be identified due to an ad hoc approach to the inclusion of data in the EPAR.Conclusions:A more systematic approach is needed on the way health outcomes data are considered, reviewed, and interpreted by the regulatory authorities. For this to be achieved, CPMP should develop general guidelines on the importance of HRQOL and how research should be conducted if data are to be included in the registration process.

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