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Pharmaceutical Education And Research with Regulatory Links: Innovative drug development strategies and regulatory tools tailored to facilitate earlier access to medicines

Total Cost €


EC-Contrib. €






 PEARRL project word cloud

Explore the words cloud of the PEARRL project. It provides you a very rough idea of what is the project "PEARRL" about.

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Project "PEARRL" data sheet

The following table provides information about the project.


Organization address
city: Cork
postcode: T12 YN60

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Ireland [IE]
 Project website
 Total cost 3˙856˙253 €
 EC max contribution 3˙856˙253 € (100%)
 Programme 1. H2020-EU.1.3.1. (Fostering new skills by means of excellent initial training of researchers)
 Code Call H2020-MSCA-ITN-2015
 Funding Scheme MSCA-ITN-ETN
 Starting year 2016
 Duration (year-month-day) from 2016-05-01   to  2020-08-31


Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
3    UNIVERSITY OF BATH UK (BATH) participant 546˙575.00
6    PION INC.(UK) LTD UK (FOREST ROW) participant 273˙287.00
7    JANSSEN PHARMACEUTICA NV BE (BEERSE) participant 250˙560.00
10    H. LUNDBECK AS DK (VALBY) participant 0.00


 Project objective

The European Pharma industry is a major contributor to EU well-being, both in public health and economic (sales >200 billion €/year) terms. To maintain global leadership, it must respond to challenges from low-cost producers e.g. China by bringing new drug molecules to market in a streamlined, cost-effective manner. This strategy is underscored by recent initiatives of European regulators to expedite the approval of “breakthrough drugs” so patients can gain earlier access to life-saving drugs. To realise these goals, scientists with an integral understanding of drug development and regulatory approval processes are urgently needed. PEARRL will train 15 Early Stage Researchers (ESR) who can develop new bio-enabling formulations (“better drugs”), biorelevant and in silico methods to predict formulation performance in vivo (“streamlined development”) and serve as communication bridgers between research and regulatory science (“accelerated approval”), thus bringing Pharma and regulatory objectives to fruition. PEARRL brings a multi-sectorial team, comprising key European regulatory authorities, academic leaders in bio-enabling formulations and biopharmaceutics tools, and an array of Pharma companies with a wealth of combined experience in bringing molecules to market, together for the first time to deliver a unique research and training programme. Key PEARRL elements are individual research projects with synergistic output; exposure of all ESR to academia, industry and regulatory in secondments; and ongoing innovative learning via Online Portals, Science Slams and Boot Camps. Key PEARRL impacts will be availability of excellent pharmaceutical researchers; streamlined drug development with a higher success rate for the industrial partners; enriched academic research through cooperation with industry and regulatory; earlier availability of breakthrough medicines to patients; a competitive pharma industry in Europe and contributions to European public health interests.


List of deliverables.
PEARRL Outreach Plan Documents, reports 2020-01-30 17:24:47
PEARRL website Websites, patent fillings, videos etc. 2020-01-30 17:24:47

Take a look to the deliverables list in detail:  detailed list of PEARRL deliverables.


year authors and title journal last update
List of publications.
2019 Ioannis Loisios-Konstantinidis, Rodrigo Cristofoletti, Nikoletta Fotaki, David B. Turner, Jennifer Dressman
Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. Case example: Naproxen
published pages: 105170, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.105170
European Journal of Pharmaceutical Sciences 2020-01-30
2019 Christina Pentafragka, Mira Symillides, Mark McAllister, Jennifer Dressman, Maria Vertzoni, Christos Reppas
The impact of food intake on the luminal environment and performance of oral drug products with a view to in vitro and in silico simulations: a PEARRL review
published pages: 557-580, ISSN: 0022-3573, DOI: 10.1111/jphp.12999
Journal of Pharmacy and Pharmacology 71/4 2020-01-30
2019 Georgia Tsakiridou, Christos Reppas, Martin Kuentz, Lida Kalantzi
A Novel Rheological Method to Assess Drug-Polymer Interactions Regarding Miscibility and Crystallization of Drug in Amorphous Solid Dispersions for Oral Drug Delivery
published pages: 625, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics11120625
Pharmaceutics 11/12 2020-01-30
2020 Marina Statelova, Konstantinos Goumas, Nikoletta Fotaki, René Holm, Mira Symillides, Christos Reppas, Maria Vertzoni
On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants: an Exploratory Study Highlighting the Importance of Infant Food
published pages: , ISSN: 1550-7416, DOI: 10.1208/s12248-019-0380-4
The AAPS Journal 22/1 2020-01-30
2019 Felix Ditzinger, Catherine Dejoie, Dubravka Sisak Jung, Martin Kuentz
Polyelectrolytes in Hot Melt Extrusion: A Combined Solvent-Based and Interacting Additive Technique for Solid Dispersions
published pages: 174, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics11040174
Pharmaceutics 11/4 2020-01-30
2019 Felix Ditzinger, Daniel J. Price, Anita Nair, Johanna Becker-Baldus, Clemens Glaubitz, Jennifer B. Dressman, Christoph Saal, Martin Kuentz
Opportunities for Successful Stabilization of Poor Glass-Forming Drugs: A Stability-Based Comparison of Mesoporous Silica Versus Hot Melt Extrusion Technologies
published pages: 577, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics11110577
Pharmaceutics 11/11 2020-01-30
2019 Mirko Koziolek, Stefano Alcaro, Patrick Augustijns, Abdul W. Basit, Michael Grimm, Bart Hens, Caroline L. Hoad, Philipp Jedamzik, Christine M. Madla, Marc Maliepaard, Luca Marciani, Annalisa Maruca, Neil Parrott, Petr Pávek, Christopher J.H. Porter, Christos Reppas, Diana van Riet-Nales, Jari Rubbens, Marina Statelova, Natalie L. Trevaskis, Kateřina Valentová, Maria Vertzoni, Dubravka Vitali Č
The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group
published pages: 31-59, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.04.003
European Journal of Pharmaceutical Sciences 134 2020-01-30
2020 Daniel J. Price, Anita Nair, Johanna Becker-Baldus, Clemens Glaubitz, Martin Kuentz, Jennifer Dressman, Christoph Saal
Incorporation of HPMCAS during loading of glibenclamide onto mesoporous silica improves dissolution and inhibits precipitation
published pages: 105113, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.105113
European Journal of Pharmaceutical Sciences 141 2020-01-30
2019 Rafael Leal Monteiro Paraiso, Ayahisa Watanabe, Cord J. Andreas, David Turner, Patricia Zane, Jennifer Dressman
In‐vitro–in‐silico investigation of the negative food effect of zolpidem when administered as immediate‐release tablets
published pages: 1663-1676, ISSN: 0022-3573, DOI: 10.1111/jphp.13161
Journal of Pharmacy and Pharmacology 71/11 2020-01-30
2019 Sandra Jankovic, Patrick J. O\'Dwyer, Karl J. Box, Georgios Imanidis, Christos Reppas, Martin Kuentz
Biphasic drug release testing coupled with diffusing wave spectroscopy for mechanistic understanding of solid dispersion performance
published pages: 105001, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.105001
European Journal of Pharmaceutical Sciences 137 2020-01-30
2018 Daniel J. Price, Felix Ditzinger, Niklas J. Koehl, Sandra Jankovic, Georgia Tsakiridou, Anita Nair, René Holm, Martin Kuentz, Jennifer B. Dressman, Christoph Saal
Approaches to increase mechanistic understanding and aid in the selection of precipitation inhibitors for supersaturating formulations - a PEARRL review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12927
Journal of Pharmacy and Pharmacology 2020-01-30
2018 Simone Aleandri, Sandra Jankovic, Martin Kuentz
Towards a better understanding of solid dispersions in aqueous environment by a fluorescence quenching approach
published pages: 130-139, ISSN: 0378-5173, DOI: 10.1016/j.ijpharm.2018.08.029
International Journal of Pharmaceutics 550/1-2 2020-01-30
2018 Joseph P. O\'Shea, René Holm, Caitriona M. O\'Driscoll, Brendan T. Griffin
Food for thought: formulating away the food effect - a PEARRL review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12957
Journal of Pharmacy and Pharmacology 2020-01-30
2018 Felix Ditzinger, Daniel J. Price, Alexandra-Roxana Ilie, Niklas J. Köhl, Sandra Jankovic, Georgia Tsakiridou, Simone Aleandri, Lida Kalantzi, René Holm, Anita Nair, Christoph Saal, Brendan Griffin, Martin Kuentz
Lipophilicity and hydrophobicity considerations in bio-enabling oral formulations approaches - a PEARRL review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12984
Journal of Pharmacy and Pharmacology 2020-01-30
2018 Mariana Guimarães, Marina Statelova, René Holm, Christos Reppas, Moira Symilllides, Maria Vertzoni, Nikoletta Fotaki
Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products - a PEARRL review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12955
Journal of Pharmacy and Pharmacology 2020-01-30
2018 Chara Litou, Angela Effinger, Edmund S. Kostewicz, Karl J. Box, Nikoletta Fotaki, Jennifer B. Dressman
Effects of medicines used to treat gastrointestinal diseases on the pharmacokinetics of coadministered drugs: a PEARRL Review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12983
Journal of Pharmacy and Pharmacology 2020-01-30
2018 Sandra Jankovic, Georgia Tsakiridou, Felix Ditzinger, Niklas J. Koehl, Daniel J. Price, Alexandra-Roxana Ilie, Lida Kalantzi, Kristof Kimpe, René Holm, Anita Nair, Brendan Griffin, Christoph Saal, Martin Kuentz
Application of the solubility parameter concept to assist with oral delivery of poorly water-soluble drugs - a PEARRL review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12948
Journal of Pharmacy and Pharmacology 2020-01-30
2017 Daniel Price, Christoph Saal, Anita Nair, Jennifer Dressman
A Novel In Silico Screening Protocol For The Selection Of Optimized Precipitation Inhibitor Systems For Supersaturable Formulations
published pages: , ISSN: , DOI:
2018 Laura J. Henze, Niklas J. Koehl, Joseph P. O\'Shea, Edmund S. Kostewicz, René Holm, Brendan T. Griffin
The pig as a preclinical model for predicting oral bioavailability and in vivo performance of pharmaceutical oral dosage forms: a PEARRL review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12912
Journal of Pharmacy and Pharmacology 2020-01-30
2018 Patrick J. O\'Dwyer, Chara Litou, Karl J. Box, Jennifer B. Dressman, Edmund S. Kostewicz, Martin Kuentz, Christos Reppas
In vitro methods to assess drug precipitation in the fasted small intestine - a PEARRL review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12951
Journal of Pharmacy and Pharmacology 2020-01-30
2018 Angela Effinger, Caitriona M. O\'Driscoll, Mark McAllister, Nikoletta Fotaki
Impact of gastrointestinal disease states on oral drug absorption - implications for formulation design - a PEARRL review
published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12928
Journal of Pharmacy and Pharmacology 2020-01-30
2017 Patrick O\'Dwyer, Karl Box, Robert Taylor, Hayley Watson
In Vitro Modelling Of Propranolol Immediate Release And Extended Release Formulations Using A Three Chamber Dissolution Apparatus
published pages: , ISSN: , DOI:
2019 Laura J. Henze, Niklas J. Koehl, Joseph P. O\'Shea, René Holm, Maria Vertzoni, Brendan T. Griffin
Toward the establishment of a standardized pre-clinical porcine model to predict food effects – Case studies on fenofibrate and paracetamol
published pages: 100017, ISSN: 2590-1567, DOI: 10.1016/j.ijpx.2019.100017
International Journal of Pharmaceutics: X 1 2020-01-30
2019 Daniel J. Price, Anita Nair, Martin Kuentz, Jennifer Dressman, Christoph Saal
Calculation of drug-polymer mixing enthalpy as a new screening method of precipitation inhibitors for supersaturating pharmaceutical formulations
published pages: 142-156, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.03.006
European Journal of Pharmaceutical Sciences 132 2020-01-30
2018 Felix Ditzinger, Uta Scherer, Monica Schönenberger, René Holm, Martin Kuentz
Modified Polymer Matrix in Pharmaceutical Hot Melt Extrusion by Molecular Interactions with a Carboxylic Coformer
published pages: 141-150, ISSN: 1543-8384, DOI: 10.1021/acs.molpharmaceut.8b00920
Molecular Pharmaceutics 16/1 2020-01-30
2019 Ioannis Loisios-Konstantinidis, Rafael L. M. Paraiso, Nikoletta Fotaki, Mark McAllister, Rodrigo Cristofoletti, Jennifer Dressman
Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review
published pages: 699-723, ISSN: 0022-3573, DOI: 10.1111/jphp.13070
Journal of Pharmacy and Pharmacology 71/4 2020-01-30
2019 Niklas J. Koehl, René Holm, Martin Kuentz, Brendan T. Griffin
New Insights into Using Lipid Based Suspensions for ‘Brick Dust’ Molecules: Case Study of Nilotinib
published pages: , ISSN: 0724-8741, DOI: 10.1007/s11095-019-2590-y
Pharmaceutical Research 36/4 2020-01-30
2019 Brendan T. Griffin, Jennifer B. Dressman
The PEARRL reviews - innovative drug development strategies tailored to facilitate earlier access to new oral medicines
published pages: 439-440, ISSN: 0022-3573, DOI: 10.1111/jphp.13083
Journal of Pharmacy and Pharmacology 71/4 2020-01-30
2019 Chara Litou, Nikunjkumar Patel, David B. Turner, Edmund Kostewicz, Martin Kuentz, Karl J. Box, Jennifer Dressman
Combining biorelevant in vitro and in silico tools to simulate and better understand the in vivo performance of a nano-sized formulation of aprepitant in the fasted and fed states
published pages: 105031, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.105031
European Journal of Pharmaceutical Sciences 2020-01-30

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