Gaois

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7 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #674689

    IATE #775430
    staidéar cógaschinéiteach Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Sa spriocspeiceas ainmhí, bíonn na staidéir chógaschinéiteacha riachtanach, de ghnáth, chun forlíonadh a dhéanamh ar staidéir chógasdinimiceacha d’fhonn tacú le bunú réimeanna dáileog sábháilte agus éifeachtacha (bealach agus suíomh tabhartha, an dáileoga, an t-eatramh dáileoige, an líon dáileog, etc.). D’fhéadfadh sé go mbeadh gá le staidéir chógaschinéiteacha bhreise chun córais dáileoige a bhunú i gcomhréir le hathróga áirithe daonra.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
    pharmacokinetic study | PK study
    en
    Definition "study aiming to examine the pharmacokinetics of a medicine" Reference "COM-Terminology Coordination, based on:Jennifer Le. Overview of Pharmacokinetics (12.7.2018). MSD Manual. Professional Version."
    Comment The pharmacokinetics of a drug depends on patient-related factors as well as on the drug’s chemical properties.
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688349

    IATE #3640697
    staidéar cógaschinéitice fachtóra eistrigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    extrinsic factor pharmaco-kinetics study | extrinsic factor PK study
    en
    Definition "human pharmacokinetic study that assesses differences in systemic exposure as a result of changes in pharmacokinetics due to extrinsic facrors" Reference "COM-Terminology Coordination, based on: EMA. 'ICH Topic M 4 E Common Technical Document for the Registration of Pharmaceuticals for Human Use – Efficacy Step 5 COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE CLINICAL OVERVIEW AND CLINICAL SUMMARY OF MODULE 2 MODULE 5: STUDY REPORTS (CPMP/ICH/2887/99 - Efficacy)' (25.7.2023). July 2003 CPMP/ICH/2887/99 - Efficacy"
    Comment Extrinsic ethnic factors are factors associated with the patient environment. Examples are the medical environment, use of other drugs (see 2.7.4.5.3, Drug Interactions), use of tobacco, use of alcohol, and food habits.
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688346

    IATE #3640694
    staidéar cógaschinéitice ar dhaoine folláine Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    healthy subjects pharmaco-kinetics study | healthy subject PK study
    en
    Definition "human pharmacokinetic study where the study population consists of healthy subjects" Reference "COM-Terminology Coordination, based on: EMA. 'ICH Topic M 4 E Common Technical Document for the Registration of Pharmaceuticals for Human Use – Efficacy Step 5 COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE CLINICAL OVERVIEW AND CLINICAL SUMMARY OF MODULE 2 MODULE 5: STUDY REPORTS (CPMP/ICH/2887/99 - Efficacy)' (25.7.2023). July 2003 CPMP/ICH/2887/99 - Efficacy"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688345

    IATE #3640693
    staidéar cógaschinéiteach an duine Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... an oibleagáid plean imscrúdaithe phéidiatraicigh a chur faoi bhráid na Gníomhaireachta agus iarraidh ar chomhaontú nó iarratas ar tharscaoileadh uaidh ann, tráth nach déanaí ná an tráth a thugtar staidéir chógaschinéiteacha an duine i gcrích ar dhaoine fásta, ach amháin i gcásanna a bhfuil údar cuí leo, dá bhforáiltear in Airteagal 76(1).' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    human pharmaco-kinetic study | human PK study | human pharmacokinetic study
    en
    Definition study in a human population of variability in drug concentrations receiving clinically relevant doses of a drug of interest Reference "Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192"
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688348

    IATE #3640696
    staidéar cógaschinéitice fachtóirí intreacha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    intrinsic factor pharmaco-kinetics study | intrinsic factor PK study
    en
    Definition "human pharmacokinetic study that assesses differences in systemic exposure as a result of changes in pharmacokinetics due to intrinsic factors" Reference "COM-Terminology Coordination, based on: EMA. 'ICH Topic M 4 E Common Technical Document for the Registration of Pharmaceuticals for Human Use – Efficacy Step 5 COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE CLINICAL OVERVIEW AND CLINICAL SUMMARY OF MODULE 2 MODULE 5: STUDY REPORTS (CPMP/ICH/2887/99 - Efficacy)' (25.7.2023). July 2003 CPMP/ICH/2887/99 - Efficacy"
    Comment "Demographic and other factors defined as ""intrinsic ethnic factors"" in ICH E5. These factors include age, sex, height, weight, lean body mass, genetic polymorphism, body composition, other illness and organ dysfunction."
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688347

    IATE #3640695
    staidéar cógaschinéitice ar othair Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    patient pharmaco-kinetics study | patient PK study
    en
    Definition "human pharmacokinetic study where the study population is selected within the intended patient population" Reference "COM-Terminology Coordination, based on: EMA. 'ICH Topic M 4 E Common Technical Document for the Registration of Pharmaceuticals for Human Use – Efficacy Step 5 COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE CLINICAL OVERVIEW AND CLINICAL SUMMARY OF MODULE 2 MODULE 5: STUDY REPORTS (CPMP/ICH/2887/99 - Efficacy)' (25.7.2023). July 2003 CPMP/ICH/2887/99 - Efficacy"
  7. SCIENCE|natural and applied sciences|life sciences|pharmacology

    #687711

    IATE #3637135
    staidéar ar chógaschinéitic phobail Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Soláthrófar tuarascálacha maidir le staidéir ar chógaschinéitic agus infhulaingt thosaigh daoine sláintiúla agus othar, tuarascálacha maidir le staidéir chógaschinéiteacha chun measúnú a dhéanamh ar éifeachtaí tosca intreacha agus eistreacha, agus tuarascálacha maidir le staidéir ar chógaschinéitic phobail.' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    population pharmaco-kinetic study | population pharmacokinetics | population pharmaco-kinetics study | popPK | population pharmacokinetic analysis | population PK study
    en
    Definition study of variability in drug concentrations within a specific population receiving clinically relevant doses of a drug of interest Reference "COM-Terminology Coordination, based on: - Allucent. 'What is Population Pharmacokinetic (popPK) Analysis?' (22.2.2023) December 5, 2018 Content updated on July 07, 2021- EMA. 'ICH Topic M 4 E Common Technical Document for the Registration of Pharmaceuticals for Human Use – Efficacy Step 5 COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE CLINICAL OVERVIEW AND CLINICAL SUMMARY OF MODULE 2 MODULE 5: STUDY REPORTS (CPMP/ICH/2887/99 - Efficacy)' (25.7.2023). July 2003 CPMP/ICH/2887/99 - Efficacy"
    Comment PopPK methods use mathematical models to describe PK data and draw conclusions. PopPK models can help guide decision-making across all phases of drug development and can also provide critical support for efficacy and safety in marketing applications such as new drug applications (NDAs) and biologics license applications (BLAs).