'PK study' — Téarmaíocht / Téarmaíocht IATE | Grúpa taighde Gaois

Léim go príomhábhar an leathanaigh

7 dtoradh

SOCIAL QUESTIONS|health|pharmaceutical industry

#674689
IATE #775430

staidéar cógaschinéiteach Tagairt "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

Comhthéacs '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.' Tagairt "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

Sainmhíniú "study aiming to examine the pharmacokinetics of a medicine" Tagairt "COM-Terminology Coordination, based on:Jennifer Le. Overview of Pharmacokinetics (12.7.2018). MSD Manual. Professional Version."
Nóta The pharmacokinetics of a drug depends on patient-related factors as well as on the drug’s chemical properties.
SOCIAL QUESTIONS|health|pharmaceutical industry

#688349
IATE #3640697

staidéar cógaschinéitice fachtóra eistrigh Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex

ga

extrinsic factor pharmaco-kinetics study | extrinsic factor PK study
en

Sainmhíniú "human pharmacokinetic study that assesses differences in systemic exposure as a result of changes in pharmacokinetics due to extrinsic facrors" Tagairt "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"
Nóta 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.
SOCIAL QUESTIONS|health|pharmaceutical industry

#688346
IATE #3640694

staidéar cógaschinéitice ar dhaoine folláine Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex

ga

healthy subjects pharmaco-kinetics study | healthy subject PK study
en

Sainmhíniú "human pharmacokinetic study where the study population consists of healthy subjects" Tagairt "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"
SOCIAL QUESTIONS|health|pharmaceutical industry

#688345
IATE #3640693

staidéar cógaschinéiteach an duine Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex

ga

Comhthéacs '... 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).' Tagairt "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

Sainmhíniú study in a human population of variability in drug concentrations receiving clinically relevant doses of a drug of interest Tagairt "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"
SOCIAL QUESTIONS|health|pharmaceutical industry

#688348
IATE #3640696

staidéar cógaschinéitice fachtóirí intreacha Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex

ga

intrinsic factor pharmaco-kinetics study | intrinsic factor PK study
en

Sainmhíniú "human pharmacokinetic study that assesses differences in systemic exposure as a result of changes in pharmacokinetics due to intrinsic factors" Tagairt "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"
Nóta "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."
SOCIAL QUESTIONS|health|pharmaceutical industry

#688347
IATE #3640695

staidéar cógaschinéitice ar othair Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex

ga

patient pharmaco-kinetics study | patient PK study
en

Sainmhíniú "human pharmacokinetic study where the study population is selected within the intended patient population" Tagairt "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"
SCIENCE|natural and applied sciences|life sciences|pharmacology

#687711
IATE #3637135

staidéar ar chógaschinéitic phobail Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex

ga

Comhthéacs '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.' Tagairt "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

Sainmhíniú study of variability in drug concentrations within a specific population receiving clinically relevant doses of a drug of interest Tagairt "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"
Nóta 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).