impact study

To investigate the effects of anagrelide and hydroxyurea on incidence of disease related thrombotic and haemorrhagic events.

Clindamycin is an effective antibiotic that has been studied in many clinical trials and used extensively in clinical practice with success.

Aware that further and more effective action to control and reduce emissions of certain heavy metals may be needed and that, for example, effects-based studies may provide a basis for further action,

(d) the establishment of an effective and preventive policy against illegal immigration, smuggling of migrants and trafficking in human beings including the issue of how to combat networks of smugglers and traffickers and how to protect the victims of such trafficking;

carry out studies to furnish advice with a view to the operation of the maximum practicable number of radio channels in those portions of the spectrum where harmful interference may occur, and with a view to the equitable, effective and economical use of the geostationary-satelliteand other satellite orbits, taking into account the needs of Member States requiring assistance, the specific needs of developing countries, as well as the special geographical situation of particular countries;

That report shall also be drawn up on the basis of a study of the socio-economic implications of the various systems and their effects on the Community's economic partners.

a study on the nature, geographical distribution, scope and financing of these measures, together with their effectiveness in relation to the objectives of the common fisheries policy and the probable outlets for fishery products in the long term;

Support and preparatory actions are those appropriate to the sound and effective management of the programme, such as the periodic monitoring and assessment referred to in point 4, studies or the networking of related projects funded under the programme.

In addition to the provisions laid down in paragraph 1, where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication.

'generic medicinal product' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.

'generic medicinal product' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.

providing the competent authorities with any other information relevant to the evaluation of the risks and benefits of a veterinary medicinal product, particularly information concerning post-authorisation safety studies, including information regarding the validity of the withdrawal period or lack of expected efficacy or potential environmental problems.

a study examining the nature, geographical distribution, scope and financing of these measures, considered in the context of the structural policies of Member States, and examining also the effectiveness of such measures in relation to the objectives of the common agricultural policy and to the long-term potential outlets normally to be anticipated for agricultural products;

In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.

majda hrženjak's study The Bio-politics of the Body in Women's Magazines is based on a survey of cosmetics advertisements published in Glamur in 2001. The author argues that in modern society women's magazines are effective vehicles for the disciplining of the female body and subjectification of the modern woman, who is seen as a consumer concerned with her image and herself. In fulfilling this task, women's magazines rely on scientific discourses (particularly those of natural sciences) while serving the interests of capital.

In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided.

Study of the effects on reproduction

Human pharmacology and efficacy studies

Reports of efficacy and safety studies

- Reports of Efficacy and Safety Studies

This shall include the results of all bio-pharmaceutics studies, of clinical pharmacology studies, and of clinical efficacy and safety studies.

Study of embryotoxic/fetotoxic effects including teratogenecity

Such studies can be more efficient in number of animals and generally provide more information than classical dose titration studies.

Member States shall carry out scenario studies and stimulation exercises in order to ensure the effectiveness of the plans.

Whereas in order to ensure the plans' effectiveness it is necessary to carry out scenarios studies and simulation exercises;

a description of the toxic effects and, for the main study, whether compound-related evident toxicity was observed;

pharmacognosy (study of the composition and effects of the active principles of natural substances of plant and animal origin).

These tests comprise studies of effect on adult male or female reproductive function, studies of the toxic and teratogenic effects at all stages of development from conception to sexual maturity as well as latent effects, when the medicinal product under investigation has been administered to the female during pregnancy.

Reports of pharmaco-kinetic and initial tolerability studies in healthy subjects and in patients, reports of pharmaco-kinetic studies to assess effects of intrinsic and extrinsic factors, and reports of population pharmaco-kinetic studies shall be provided.

(8) Member States shall carry out scenario studies and simulation exercises in order to ensure the effectiveness of the plans.

In this respect, reports of plasma protein binding studies, hepatic metabolism and active substance interaction studies and studies using human bio-materials shall be provided.

Pharmaco-kinetics means the study of the fate of the active substance, and its metabolites, within the organism, and covers the study of the absorption, distribution, metabolism (bio-transformation) and excretion of these substances.

The following data were obtained from an international method performance study carried out to internationally agreed procedures.

Where constituents other than the active substance(s) are incriminated, validation of their removal may replace the study.

The following data were obtained from an international method performance study carried out to internationally agreed procedures [1] [2].

ensure that the quality assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the quality assurance personnel as required during the conduct of the study,

evaluate the effectiveness of the actions decided upon, notably on the basis of the reports of the Contracting Parties and the results of the measuring programmes and studies of the Rhine ecosystem;

In order to monitor the consequent effects of the exploration phase of the offshore activity studies, at least those referred to in subparagraph (d), shall be carried out before and after the operation.

If such a medicinal product is intended to be administered chronically to humans a chronic study may be necessary to detect early tumorigenic effects.

(b) ensure that the quality assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the quality assurance personnel as required during the conduct of the study;

In target species, pharmacokinetic studies are, as a rule, necessary in order to employ drugs with the greatest possible efficacy and safety.

In all investigations of toxic effects, the temperature and humidity should be monitored, recorded, and included in the final report of the study.

all relevant information on the plant protection product as provided for in Annex III, including toxicological studies and efficacy data.

(b) carrying out comparative studies to ensure that safety and potency testing in each Member State is carried out by comparable methodology;

Particular attention shall be paid to the study of low-dose effects and of remedying contaminated areas, to industrial and medical exposure and post-accident management.

Furthermore, solid pharmaceutical forms having to be administered orally shall be subjected to in vitro studies on the liberation and dissolution rate of the active substance or substances;

The implementation of measures adopted under Article 11(h) pursuant to the results of the feasibility studies shall make possible the transmission of data for the first quarter of 2007, provided that the results of the feasibility studies allow for the cost-effective production of data of sufficient quality.

b) The documentation submitted by the applicant should cover all aspects of the safety and/or efficacy assessment and must include or refer to a review of the relevant literature, taking into account pre- and post-marketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies.

In some cases, inspectors may need assistance from other experts in order to conduct an effective study audit, for example, where there is a need to examine tissue sections under the microscope.