is contrary to the obligation laid down in article 2, thereby committing, per se, a violation to which the Committee should refer in its decision, in addition to the violations found, because the author and her son have been the victims — inter alia — of that provision of the law. ...
reducedrequirementincomparisontoapprovalforanew drugentity.Thegenericdrugsneedtoshowbioequiva- lencetotheinnovatordrugstypicallybasedonpharma- cokineticparameterssuchastherateofabsorptionor bioavailabilityin24to36healthyvolunteers.Nolarge Drug2008SalesYearapprovedDrug2008SalesYearapproved Avastin$9.22004Avonex$2.61996 En...
The storm wave direction varies from northeast through to south depending on the source: tropical cyclones; east-coast lows; or intensified mid-latitude cyclones. In this study, the XBeach numerical model was used in phase-averaged (surfbeat), profile (1DH) mode at the cross-shore transect (...
Therefore, in the long run, the HTL process could help lower production costs, due to the lack of chemical additions, for extracting oil in the downstream estimation of the energy requirements for microalgae oil production. Keywords: microalgae; energy requirement; hydrothermal liquefaction; energy ...
Biogas energy can be an alternative in providing clean energy for cooking as well as improving soil fertility with the slurry. However, the labor spent on producing biogas can limit its use as a source of energy and fertilizers. Therefore, this study aims to determine the labor requirement of...
LawFood,DrugandCosmeticAct(FD&C)PublicHealthServiceAct(PHS) DrugapplicationNewDrugApplication(NDA)BiologicLicenseApplication(BLA) Genericapplication AbbreviatedNewDrugApplication (ANDA) Nopathwayyet ComparisonpropertySmall-moleculegenericsBiosimilars Productcharacteristics Small,simplemolecule (Molecularweight:100-1,000...