A toolbox for mimicking gastrointestinal conditions in children: Design and evaluation of biorelevant dissolution media for mimicking paediatric gastric- and small intestinal conditions

Fed intestinal solubility limits and distributions applied to the Developability classification system

(2023) Maria Inês Silva et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Vehicles for Drug Administration to Children: Results and Learnings from an In-Depth Screening of FDA-Recommended Liquids and Soft Foods for Product Quality Assessment

(2022) Lisa Freerks et al.   PHARMACEUTICAL RESEARCH

Structured solubility behaviour in bioequivalent fasted simulated intestinal fluids

(2022) Qamar Abuhassan et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Patient-specific in vitro drug release testing coupled with in silico PBPK modeling to forecast the in vivo performance of oral extended-release levodopa formulations in Parkinson’s disease patients

(2022) Erik Wollmer et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Review of paediatric gastrointestinal physiology relevant to the absorption of orally administered medicines

(2021) Erik Wollmer et al.   ADVANCED DRUG DELIVERY REVIEWS

Measuring pH and Buffer Capacity in Fluids Aspirated from the Fasted Upper Gastrointestinal Tract of Healthy Adults

(2020) Chara Litou et al.   PHARMACEUTICAL RESEARCH

In Vivo Predictive Dissolution Testing of Montelukast Sodium Formulations Administered with Drinks and Soft Foods to Infants

(2020) J. Martir et al.   AAPS PHARMSCITECH

A Biopredictive In Vitro Approach for Assessing Compatibility of a Novel Pediatric Hydrocortisone Drug Product within Common Pediatric Dosing Vehicles

(2020) Erik Wollmer et al.   PHARMACEUTICAL RESEARCH

Characterisation of fasted state gastric and intestinal fluids collected from children

(2020) Gopal Pawar et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Commentary on the EMA R eflection P aper on the use of extrapolation in the development of medicines for paediatrics

(2019) Cécile Ollivier et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios of nifedipine and lorazepam

(2019) A.C. Vossen et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A review of GI conditions critical to oral drug absorption in malnourished children

(2019) Lisa Freerks et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Magnetic Resonance Imaging Quantification of Gastrointestinal Liquid Volumes and Distribution in the Gastrointestinal Tract of Children

(2019) Eleni Papadatou-Soulou et al.   MOLECULAR PHARMACEUTICS

Application of the GastroDuo as an in Vitro Dissolution Tool To Simulate the Gastric Emptying of the Postprandial Stomach

(2019) Philipp Schick et al.   MOLECULAR PHARMACEUTICS

Gastric fluid composition in a paediatric population: Age-dependent changes relevant for gastrointestinal drug disposition

(2018) Jens Van Den Abeele et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

A Biopredictive In Vitro Comparison of Oral Locally Acting Mesalazine Formulations by a Novel Dissolution Model for Assessing Intraluminal Drug Release in Individual Subjects

(2018) Frank Karkossa et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Assessing the influence of media composition and ionic strength on drug release from commercial immediate-release and enteric-coated aspirin tablets

(2017) Frank Karkossa et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs

(2017) Bart Hens et al.   MOLECULAR PHARMACEUTICS

Simulating Different Dosing Scenarios for a Child-Appropriate Valproate ER Formulation in a New Pediatric Two-Stage Dissolution Model

(2016) Frank Karkossa et al.   AAPS PHARMSCITECH

In Vitro Model Simulating Gastro-Intestinal Digestion in the Pediatric Population (Neonates and Young Infants)

(2016) Danna Kamstrup et al.   AAPS PHARMSCITECH

An in vitro biorelevant gastrointestinal transfer (BioGIT) system for forecasting concentrations in the fasted upper small intestine: Design, implementation, and evaluation

(2016) Alexandros Kourentas et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Extrapolation of efficacy and other data to support the development of new medicines for children: A systematic review of methods

(2016) Ian Wadsworth et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

Assessment of Age-Related Changes in Pediatric Gastrointestinal Solubility

(2015) Anil R. Maharaj et al.   PHARMACEUTICAL RESEARCH

Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report

(2014) Christos Reppas et al.   PHARMACEUTICAL RESEARCH

Development of a bio-relevant dissolution test device simulating mechanical aspects present in the fed stomach

(2013) Mirko Koziolek et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

In vitro models for the prediction of in vivo performance of oral dosage forms

(2013) Edmund S. Kostewicz et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Darunavir: A Critical Review of Its Properties, Use and Drug Interactions

(2012) Josilene Chaves Ruela Corrêa et al.   PHARMACOLOGY

Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs

(2011) J. Dunne et al.   PEDIATRICS

The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug

(2010) Sandra Klein   AAPS Journal

A biorelevant dissolution stress test device – background and experiences

(2010) Grzegorz Garbacz et al.   Expert Opinion on Drug Delivery

A Standardized Mini Paddle Apparatus as an Alternative to the Standard Paddle

(2008) Sandra Klein et al.   AAPS PHARMSCITECH

Use of the BioDis to generate a physiologically relevant IVIVC

(2008) S KLEIN et al.   JOURNAL OF CONTROLLED RELEASE

Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update

(2008) Ekarat Jantratid et al.   PHARMACEUTICAL RESEARCH