The innovative medicines initiative IMIA new collaborative approach to drug safety testing and beyond

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  • Abstracts / Toxicology Letters 189S (2009) S57S273 S265

    adjust the dosing schedule, according to the needs and responsesof patients under treatment.

    doi:10.1016

    P27Developmetrophoresishuman pla

    Miriana Gu

    UMF Carol D

    The bioavadonepezil radjusting ddesirable to

    A simpleillary electrdeveloped a

    Optimuma64.5 cm (5nonaqueouinmethano25kV. Injec10 s). In the14.410.15

    The cali(R2 > 0.992)less than 10levels.

    The resumonitor plaassess patie

    doi:10.1016

    P28The neuropdiabetic ne

    Marzieh Pa

    JundishapouRepublic of I

    Diabetic neaffectingmcause of noroactive steidentied aof neurodegneuroproteneuropathyrats in eachPROG-treatdose injectitreated grouwith PROGshowed a si(MNCV), mand myelinIn the untre

    in sciatic nerve and the numbers of MFs with infolding into theaxoplasm, irregularity of bers, myelin sheathwith unclear bound-aries and alteration in myelin compaction were also increased.

    erm tteds induroperal d

    ds: Ption

    1016

    novach t

    as Go

    cherl R&

    e hugdev

    mitereasoty an004s thefun

    tioner whichs, brnies,ities.008veraappplan

    cted

    1016

    protinag

    Hass3, M

    cedn UnUniv

    studtoxicinjecind

    andacid/j.toxlet.2009.06.395

    nt and validation of a nonaqueous capillary elec-method for the quantication of donepezil in

    sma

    bandru , Dan Balalau, Mihaela Ilie, Carmen Purdel

    avila, Toxicology, Bucharest, Romania

    ilability and non-compliance to treatment withepresent major issues, mainly in clinical trials andose settings, so frequently drug-level measurement is aol to improve clinical outcomes with Alzheimer drugs., rapid and sensitive procedure using nonaqueous cap-ophoresis (NACE) to measure donepezil levels has beennd validated.detection of donepezil was obtained at 315nm, using

    6 to thedetector)50mi.d. fused-silica capillary. Thes mobile phase consisted in 15mM ammonium acetatelacetonitrile (7:3, v/v), the operating voltagewas set attionwas performed in the hydrodynamicmode (0.5psi,se conditions, the peak of donepezil was obtained atmin.bration curve was linear in the range of 0.55g/mL. Intra/interday accuracy and precisionwere found to be% and 5%, respectively, at three control concentration

    lts obtained prove that the NACE method is suitable tosma levels of donepezil and can properly be used tonts compliance to medication.

    /j.toxlet.2009.06.396

    rotective effects of progesterone on experimentaluropathy in rats

    nahi , Mohammadreza Sameni

    r Ahwaz University, Anatomical Sciences, Ahwaz, Islamicran

    uropathy is one of the most common complicationsore than 5060% of diabetic patients and it is a commonn-traumatic amputation and autonomic failure. Neu-roids, such as progesterone (PROG), have been recentlys promising neuroprotective agents in several modelseneration. In this study we investigated the potential

    ctive effect of PROG in experimental model of diabetic. Animalswere randomly divided into 3 groups (with 10), control (nondiabetic), untreated diabetic and diabeticed. Diabetes was induced in adult male rats by a singleon of streptozotocin (STZ, 55mgkg1, i.p.). In the PROG-p, 4 weeks after induce of diabetes; rats were treated

    (8mgkg1, i.p., every 2 days) for 6 weeks. Diabetic ratsgnicant reduction in motor nerve conduction velocityean myelinated bers (MFs) diameter, axon diametersheath thickness in the sciatic nerve after 6 weeks.ated diabetic group endoneurial edema was observed

    Long-tprevenndingtect neperiph

    Keyworconduc

    doi:10.

    P29The inapproa

    Matthi

    Bayer SExterna

    Despitof drugwith limajorof safe

    In 2addresequallyFederaTogethoped wprojectcompaauthor

    In 2with seorativefuture

    Sele

    doi:10.

    P30Hepatocatechrats

    SohairBadary

    1 Advan2 HelwaShams

    In thishepatotonealon thestatusphyticreatment with PROG increasedMNCV signicantly andall these abnormalities in treated diabetic rats. Ouricated that PROG as a therapeutic approach can pro-hysiologic andhistomorphologic alterations induced byiabetic neuropathy.

    rogesterone; Sciatic nerve; Diabetic neuropathy; Nervevelocity; Histomorphometry

    /j.toxlet.2009.06.397

    tive medicines initiative IMIA new collaborativeo drug safety testing and beyond

    ttwald

    ing Pharma AG, Global Drug Discovery Operations -D Policy, Berlin, Germany

    e spendings in pharmaceutical R&D, the attrition rateelopment projects is still at an unacceptable high leveld safety and/or efcacy of the tested compounds beingns. Validated methods for an early reliable predictiond efcacy of new medicines are urgently needed.the idea for a new collaborative approach was born tose issues via a new publicprivate-partnership model,ded by the European Commission and the Europeanof Pharmaceutical Industries and Associations EFPIA.ith all stakeholders a research agenda has been devel-sets the frame for annual rounds of big collaborativeinging together experts from many pharmaceuticalacademia, SMEs, patient organisations and public

    the rst call for proposal within IMI has been publishedl topics in the area of safety prediction. The new collab-roach of IMI and an overview on the rst projects ands will be presented.

    for Oral Presentation.

    /j.toxlet.2009.06.398

    ective and antioxidant activity of phytic acid and/orainst carbon tetrachloride-inducedhepatotoxicity in

    an1,, Maha Zaki Rizk1, Fathia El-Sharkawi2, Osamaai Osman Kadry3

    Dental and Medical Institute, Biochemistry, Pinang, Egypt,iversity, Biochemistry Department, Helwan, Egypt, 3 Ain

    ersity, Clinical Pharmacy Department, Ain Shams, Egypt

    y, the rat model of carbon tetrachloride (CCl4)-inducedity was used to assess the effect of daily intraperi-tions of catechin, phytic acid and their combinationices of cirrhosis. Liver enzymes proling, oxidativehistological examinations revealed that catechin andsignicantly arrested progression of hepatic cirrho-

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