Suchergebnisse

Complex drugs may be either biological, if the active ingredients are derived from a biological source, or non-biological, if obtained by chemical synthesis. In both cases, their quality depends considerably on the manufacturing process. In the case of Non Biological Complex Drugs (NBCDs), complexity may arise either from the active substance, as in the case of glatiramer acetate, or from other sources, such as the formulation, as in the case of liposomes. In this paper, the case of glatiramer acetate (GA) - a NBCD relevant for clinical and economic reasons - is considered and the differences between US and EU regulatory approaches to GA marketing authorization are highlighted. Indeed, though US and EU regulatory agencies have chosen a generic approach integrated with additional data the implementation is different in the two jurisdictions. In the US, the additional data required are listed in a product specific guideline and copies of Copaxone® have been approved as generics. In the EU, instead regulatory agencies followed a hybrid approach requiring an additional comparative study, and interchangeability policies and substitution schemes have been left to national agencies.

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, chloroquine phosphate, were summarized in this report. ; U.S. Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: 5U01FD005946

Rock phosphates are less soluble and agronomically not as efficient as the acidulated. However, some rhizobacteria can improve the solubilization of inorganic phosphates in the soil, raising the efficiency of the rock phosphates. The objective was to evaluate the development of maize plants in response to the application of soluble and rock P sources associated with rhizobacteria inoculation. A greenhouse experiment was carried out with six P sources: no P application; ​​Triple Superphosphate (TSPh); Gafsa rock phosphate (reactive); Itafós rock phosphate (non-reactive); TSPh + Gafsa; and TSPh + Itafós, and three inoculation forms: no inoculation, Burkholderia pickettii GN 2214 and Pseudomonas sp. fluorescens group P21. Plant height, stem diameter, leaf area, shoot dry weight (ShDW), root dry weight (RDW), total dry weight, cumulative P content in ShDW, RDW/ShDW ratio and relative agronomic efficiency were assessed. Agronomic efficiency and growth of the TSPh-treated plants were better than of those treated with rock phosphates. The association of TSPh with rock phosphates increases the agronomic efficiency and maize plant growth more than the isolated rock sources. Inoculation with P. fluorescens strain P21, improved the performance of maize fertilized with Gafsa phosphate, but had no effect when associated with Itafós phosphate. Together with TSPh, inoculation intensified shoot and root growth, indicating the potential to increase the efficiency of soluble sources as well.