5246 results
Type of content
Others Remove Others filter
-
List item
Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 05/06/2020Clinical pharmacology and pharmacokinetics: questions and answers … issues related to clinical pharmacology and pharmacokinetics. … comments) 31 May 2010 Agreed by Pharmacokinetics Working Party (PKWP) June …
-
List item
ICH E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories
Last updated: 01/11/2007Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding … terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers pharmacogenomics, … Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding …
-
List item
Pharmacovigilance: Overview
Last updated: 13/11/2020Pharmacovigilance: Overview … Pharmacovigilance is the science and activities … coordinates the European Union (EU) pharmacovigilance system and operates services …
-
List item
Pharmacovigilance: post-authorisation
Last updated: 28/03/2017Pharmacovigilance: post-authorisation … EMA) to follow a number of pharmacovigilance processes after a product …
-
List item
Pharmacovigilance: research and development
Last updated: 28/03/2017Pharmacovigilance: research and development … the sections below: Good pharmacovigilance practices : see Modules I Pharmacovigilance systems) and II Pharmacovigilance system master file) Patient …
-
List item
Pharmacovigilance: marketing authorisation
Last updated: 28/03/2017Pharmacovigilance: marketing authorisation … of a medicine and future pharmacovigilance activies designed to further … clinical data. They support pharmacovigilance activities and are often …
-
List item
Pharmacovigilance: Regulatory and procedural guidance
Last updated: 29/04/2016Pharmacovigilance: Regulatory and procedural … facilitate the performance of pharmacovigilance activities in the European … key deliverable of the 2010 pharmacovigilance legislation to replace earlier …
-
List item
Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics)
Last updated: 21/10/1999Development pharmaceutics for biotechnological and … for guidance on development pharmaceutics) … Pharmaceutical development, biological …
-
List item
Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use”
Last updated: 01/03/2004Control of impurities of pharmacopoeial substances: compliance with … compliance with the European Pharmacopoeia general monograph “Substances … monograph “Substances for Pharmaceutical Use” and general chapter …
-
List item
Non-clinical: pharmacology and safety pharmacology
Last updated: 25/05/2016Non-clinical: pharmacology and safety pharmacology … guidelines on non-clinical pharmacology help medicine developers …
-
List item
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
Last updated: 24/11/2017opean Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP … European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) brings together … expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe …
-
List item
Clinical efficacy and safety: clinical pharmacology and pharmacokinetics
Last updated: 26/03/2010efficacy and safety: clinical pharmacology and pharmacokinetics … scientific guidelines on clinical pharmacology and pharmacokinetics help medicine developers …
-
List item
ICH S7A Safety pharmacology studies for human pharmaceuticals
Last updated: 01/06/2001ICH S7A Safety pharmacology studies for human pharmaceuticals … recommendations for safety pharmacology studies. It applies to new … also be applied to marketed pharmaceuticals when appropriate (e.g. when …
-
List item
Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
Last updated: 27/07/2000Pharmacokinetics and pharmacodynamics in the development of antibacterial … considers the implication of pharmacokinetics/pharmacodynamics relationship for the development … Points To Consider On Pharmacokinetics and Pharmacodynamics in the development of antibacterial …
-
List item
ICH S3B Pharmacokinetics: repeated dose tissue distribution studies
Last updated: 30/11/1994ICH S3B Pharmacokinetics: repeated dose tissue distribution … effective version ICH: S 3 B: Pharmacokinetics: Guidance for repeated dose … human clinical trials for pharmaceuticals ICH S3A Toxicokinetics: the …
-
List item
Addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
Last updated: 07/07/2017on terms and concepts of pharmacogenomic features related to metabolism … the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal produ … the guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products …
-
List item
Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population
Last updated: 01/02/2018paper on investigation of pharmacokinetics and pharmacodynamics in the obese population … Thus, the need for adequate pharmacokinetic (PK) characterisation in … paper on investigation of pharmacokinetics and pharmacodynamics in the obese population …
-
List item
Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
Last updated: 26/07/2016Use of pharmacokinetics and pharmacodynamics in the development of antibacterial … inhibitory concentration, pharmacokinetic-pharmacodynamic index, magnitude, target …
-
List item
Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products
Last updated: 20/11/2015Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal produ … addresses the influence of pharmacogenomics on pharmacovigilance activities. It includes considerations … considerations on how to evaluate the pharmacovigilance related issues for medicinal …
-
List item
Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
Last updated: 02/02/2012Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal produ … addresses the influence of pharmacogenetics on drug pharmacokinetics, encompassing considerations … Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products …
-
List item
Pharmacovigilance
Last updated: 08/07/2020Pharmacovigilance … Veterinary pharmacovigilance concerns monitoring, evaluating … Veterinary Medicines Division Pharmacovigilance-related regulatory recommendations …
-
List item
Pharmaceutical industry
Last updated: 22/01/2021Pharmaceutical industry … The pharmaceutical industry is one of the European … stakeholders. Interacting with pharmaceutical companies has been a major …
-
List item
Pharmaceutical industry
Last updated: 16/12/2020Pharmaceutical industry … Pharmaceutical industry …
-
List item
Good pharmacovigilance practices
Last updated: 03/02/2021Good pharmacovigilance practices … Good pharmacovigilance practices (GVP) are a set … facilitate the performance of pharmacovigilance in the European Union (EU …
-
List item
Pharmacovigilance
Last updated: 31/12/2009Pharmacovigilance … Human Veterinary Topics: Pharmacovigilance …