Clinical efficacy and safety: Clinical pharmacology and pharmacokinetics

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This page lists the European Medicines Agency's scientific guidelines on clinical pharmacology and pharmacokinetics, which concern the study of medicines and their action in the human body.

If you have comments on a document that is open for consultation, use the form for submission of comments on scientific guidelines.

Please note that the Efficacy Working Party secretariat e-mail address (ewpsecretariat@ema.europa.eu) no longer exists. Therefore, please submit your comments from now on to the following e-mail address: pkwpsecretariat@ema.europa.eu.

TopicDocumentsReference numberPublication dateEffective dateRemarks
Qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and analysesConcept paper EMA/CHMP/211243/2014Released for consultation June 2014 Deadline for comments 30 September 2014
Sunitinib product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423716/2013Released for consultation December  2013 Deadline for comments 3 March 2014
Capecitabine product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423732/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Carglumic acid product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/422457/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Dasatinib product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423718/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Emtricitabine/tenofovir disoproxil product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423726/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Erlotinib product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/418988/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Imatinib product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423733/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Memantine product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423734/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Miglustat product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/422796/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Oseltamivir product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423665/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Posaconazole product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423719/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Repaglinide product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/422421/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Sirolimus product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/422569/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Sorafenib product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423707/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Tadalafil product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423735/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Telithromycin product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/422605/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Voriconazole product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/422408/2013Released for consultation November 2013 Deadline for comments 15 February 2014
Development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tractConcept paperEMA/CHMP/558326/2013Released for consultation October 2013 Deadline for comments 31 December 2013
Development of product-specific guidance on demonstration of bioequivalenceConcept paperEMA/CHMP/423137/2013Released for consultation August 2013 Deadline for comments 30 September 2013
Pharmacokinetic and clinical evaluation of modified-release dosage forms

Draft guideline

 

EMA/CHMP/EWP/280/96 Rev. 1

Released for consultation March 2013

 

 

 

Deadline for comments 15 September 2013
Modified-release oral and transdermal dosage forms: Section IIAdopted guidelineEMA/CPMP/EWP/280/96 Corr.1 (28/05/09)July 1999January 2000 
Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product

Overview of comments

Adopted reflection paper

Draft reflection paper

EMA/CHMP/806058/2009/Rev. 2

 

March 2013  
Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Adopted guideline

Draft guideline

Concept paper

EMA/CHMP/37646/2009Released for consultation April 2010 Deadline for comments 31 October 2010
Investigation of drug interactions

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CPMP/EWP/560/95/Rev. 1July 2012January 2013 
Investigation of drug interactionsAdopted guidelineCPMP/EWP/560/95   
Investigation of bioequivalence

Overview of comments

Adopted guideline

Draft guideline

Concept paper

Concept paper

CPMP/EWP/QWP/1401/98 Rev. 1January 2010August 2010 
Appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1

Overview of comments

Adopted guideline

Draft guideline

 

EMA/CHMP/600958/2010November 2011June 2012 
Positions on specific questions addressed to the
Pharmacokinetics Working Party

Questions and answers

EMA/618604/08 Rev. 8October 2013  
Bioanalytical method validation

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMEA/CHMP/EWP/192217/09August 2011February 2012 
Clinical investigation of the pharmacokinetics of therapeutic proteins

Overview of comments

Adopted guideline

Draft guideline

CPMP/EWP/89249/04February 2007July 2007 
Role of pharmacokinetics in the development of medicinal products in the paediatric population

Overview of comments

Adopted guideline

CHMP/EWP/147013/04July 2006January 2007 
Need to develop an appendix to the guideline on bioequivalence regarding the presentation of biopharmaceutical and bioanalytical data in application dossiersConcept paperEMA/CHMP/EWP/82259/2010Released for consultation April 2010 Deadline for comments 31 July 2010
Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products

Overview of comments

Adopted guideline

Draft guideline

CHMP/SWP/28367/07July 2007September 2007 
Reporting the results of population pharmacokinetic analyses

Overview of comments

Adopted guideline

Draft guideline

CHMP/EWP/185990/06July 2007January 2008 
Addendum to the note for guidance on the investigation of bioavailability and bioequivalence: Evaluation of bioequivalence of highly variable drugs and drug products CHMP/EWP/147231/06  Deleted.
This topic will be addressed in the revision of the note for guidance on the investigation of bioavailability and bioequivalence (CHMP/EWP/200943/07)
Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic functionAdopted guidelineCPMP/EWP/2339/02February 2005August 2005 
Need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal functionConcept paperEMA/CHMP/203926/2012Released for consultation June 2012 Deadline for comments 31 July 2012
Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

Draft guideline

Adopted guideline

EMA/83874/2014 Rev1Released for consultation March 2014 Dealine for comments 31 August 2014
Points to consider on the clinical requirements of modified-release products released as a line extension of an existing marketing authorisationAdopted guidelineCPMP/EWP/1875/03December 2003June 2003 
Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal productsAdopted guidelineCPMP/EWP/2655/99July 2000February 2001 
Need for revision of the note for guidance on modified-release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation)Concept paperEMA/CHMP/1303/2010Released for consultation May 2010 Deadline for comments 31 August 2010
Pharmacokinetic studies in manAdopted guideline3CC3AOctober 1998