Search PubMed⌕ Search

Biomedical subjects

F Sauer

Publications and source records attributed to F Sauer.

At least 55 records · Page 3Linked to original sources
PubMed1993

[European drug policy].

The European harmonization of pharmaceutical legislation was completed in 1992, but the harmonization of marketing authorizations still requires the creation of an "European medicines evaluation agency", From january 1995, two complementary marketing authorization procedures will have to be established for human and veterinary medicines in the European Community: a decentralised procedure for most products, and a centralised procedure, only valid for innovative products. At the same time, a better coordination of the assessment of adverse drug reactions (pharmacovigilance) should be achieved.

Animals↗
PubMed1992

Transcriptional control by Drosophila gap genes.

The segmented body pattern along the longitudinal axis of the Drosophila embryo is established by a cascade of specific transcription factor activities. This cascade is initiated by maternal gene products that are localized at the polar regions of the egg. The initial long-range positional information of the maternal factors, which are transcription factors (or are factors which activate or localize transcription factors), is transferred through the activity of the zygotic segmentation genes. The gap genes act at the top of this regulatory hierarchy. Expression of the gap genes occurs in discrete domains along the longitudinal axis of the preblastoderm and defines specific, overlapping sets of segment primordia. Their protein products, which are DNA-binding transcription factors mostly of the zinc finger type, form broad and overlapping concentration gradients which are controlled by maternal factors and by mutual interactions between the gap genes themselves. Once established, these overlapping gap protein gradients provide spatial cues which generate the repeated pattern of the subordinate pair-rule gene expression, thereby blue-printing the pattern of segmental units in the blastoderm embryo. Our results show different strategies by which maternal gene products, in combination with various gap gene proteins, provide position-dependent sets of transcriptional activator/repressor systems which regulate the spatial pattern of specific gap gene expression. Region-specific combinations of different transcription factors that derive from localized gap gene expression eventually generate the periodic pattern of pair-rule gene expression by the direct interaction with individual cis-acting "stripe elements" of particular pair-rule gene promoters. Thus, the developmental fate of blastoderm cells is programmed according to their position within the anterior-posterior axis of the embryo: maternal transcription factors regulate the region-specific expression of first zygotic transcription factors which, by their specific and unique combinations, control subordinate zygotic transcription factors, thereby subdividing the embryo into increasingly smaller units later seen in the larva.

Animals↗
PubMed1991

Concentration-dependent transcriptional activation or repression by Krüppel from a single binding site.

One of the gap class of segmentation genes, Krüppel (Kr), is required for normal thorax and abdominal development of the Drosophila embryo. Its gene product, a zinc-finger type protein, forms a bell-shape concentration gradient in a central position of the blastoderm. Genetic and molecular studies suggested that the Kr protein (KR) may act both as a positive and as a negative regulator of transcription on several other genes of the zygotic segmentation hierarchy. We have examined the regulatory potential of Kr by a series of cotransfection experiments in the Drosophila Schneider cell line system. Different doses of Kr expression plasmid were tested for their ability to drive reporter gene expression mediated by a single 11-base pair KR in vitro binding site common to several putative Kr target genes. Our results show that low amounts of Kr expression plasmid lead to transcriptional activation, whereas high amounts result in repression. Distinct portions of KR other than the DNA-binding domain are required for gene activation and repression, suggesting that KR itself can act as a concentration-dependent positive and negative regulator of transcription.

Animals↗
PubMed1990

Drug safety in the European community.

By 1992 the European Community's pharmaceutical legislation will cover all industrially produced medicines, including vaccines, blood products and radiopharmaceuticals. The quality, safety and efficacy requirements have been harmonised, as have certain aspects of procedures for marketing authorisation or for manufacture. The complete texts of the 'Rules Governing Medicinal Products in the European Community' were published recently. Pharmaceutical companies have 2 types of European Community registration procedures available, which are intended to facilitate the adoption of a common position by the member states. The experience gained with the procedures of the Committee for Proprietary Medicinal Products (CPMP) has highlighted opportunities for closer cooperation, either before national decisions (concertation procedure) or after such decisions (multi-state procedure). The installation, in 1993, of a single European market without borders implies that medicinal products should be able to circulate throughout the European Community with the same conditions attached to their marketing. Monitoring the adverse effects of medicinal products (pharmacovigilance) is also a major issue. The existing arrangements for exchanging postmarketing information will be reinforced, in future, by strengthening the legal provisions already in force.

Drug-Related Side Effects and Adverse Reactions↗
PubMed1987

Rules governing pharmaceuticals in the European Community.

In the interest of public health, the European community has progressively established common scientific criteria for the evaluation of human and veterinary medicines and harmonized the national authorization procedures. One major consequence of this has been that neither the tests and trials carried out to obtain authorization nor batch controls need be repeated within the European community. Henceforth the pharmaceutical industry may benefit from two types of procedures intended to facilitate the registration of their medicinal products in the member states. One, reserved for biotechnology/high technology medicinal products, involves community coordination prior to any national decision together with special protection against copies for ten years, irrespective of the position under patent law. The other enables firms to request the recognition by the other member states of an authorization previously granted by one member state. The experience gained from these two procedures will lead to the choice of the most appropriate European registration procedure for the next decade. In the interests of the European consumer, cooperation between the 12 member states and the Commission of the European Communities has progressively increased within the Committee for Proprietary Medicinal Products (adverse effects of medicines/pharmacovigilance) and the Committee for Veterinary Medicinal Products (residues). In association with these committees, several working groups of experts attempt to approximate and codify practices in the evaluation of the quality, safety, and efficacy of medicinal products (guidelines).(ABSTRACT TRUNCATED AT 250 WORDS)

Commerce↗
PubMed1977

Secondary amenorrhea associated with balanced X-autosome translocation.

This is the first reported instance of a patient with gonadal dysgenesis that involves translocation of part of the long arm of an X chromosome to the short arm of a number 7 autosome. The importance of considering gonadal dysgenesis early in the evaluation of patients with secondary amenorrhea considered for ovulation induction is stressed. The relation between chromosomal rearrangement, phenotypic expression, and clinical presentation is discussed.

Adult↗