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Biopharmaceutical aspects and implications of excipient variability in drug product performance

European journal of pharmaceutics and biopharmaceutics, 2017-02, Vol.111, p.1-15

2017

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BCS-based biowaivers: Extension to paediatrics

European journal of pharmaceutical sciences, 2020-12, Vol.155, p.105549-105549, Article 105549

2020

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Surface dissolution UV imaging for characterization of superdisintegrants and their impact on drug dissolution

International journal of pharmaceutics, 2020-03, Vol.577, p.119080-119080, Article 119080

2020

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Impact of Food and Drink Administration Vehicles on Paediatric Formulation Performance: Part 1—Effects on Solubility of Poorly Soluble Drugs

AAPS PharmSciTech, 2020-06, Vol.21 (5), p.177-177, Article 177

2020

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

AAPS PharmSciTech, 2020-10, Vol.21 (7), p.282, Article 282

2020

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Biopharmaceutical implications of excipient variability on drug dissolution from immediate release products

European journal of pharmaceutics and biopharmaceutics, 2020-09, Vol.154, p.195-209

2020

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Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties: Case Study—Hypromellose (HPMC)

The AAPS journal, 2020-02, Vol.22 (2), p.49, Article 49

2020

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BU08073 a buprenorphine analogue with partial agonist activity at μ‐receptors in vitro but long‐lasting opioid antagonist activity in vivo in mice

British journal of pharmacology, 2015-01, Vol.172 (2), p.668-680

2015

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An in vitro–in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics

International journal of pharmaceutics, 2016-02, Vol.499 (1-2), p.330-342

2016

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In vitro - in vivo relations for the parenteral liposomal formulation of Amphotericin B: A clinically relevant approach with PBPK modeling

European journal of pharmaceutics and biopharmaceutics, 2021-02, Vol.159, p.177-187

2021

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Understanding and predicting the impact of critical dissolution variables for nifedipine immediate release capsules by multivariate data analysis

International journal of pharmaceutics, 2017-02, Vol.518 (1-2), p.41-49

2017

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A comparative study of different release apparatus in generating in vitro– in vivo correlations for extended release formulations

European journal of pharmaceutics and biopharmaceutics, 2009-09, Vol.73 (1), p.115-120

2009

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Investigation and simulation of dissolution with concurrent degradation under healthy and hypoalbuminaemic simulated parenteral conditions- case example Amphotericin B

European journal of pharmaceutics and biopharmaceutics, 2018-06, Vol.127, p.423-431

2018

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In vitro in vivo relations for the parenteral liposomal formulation of Amphotericin B: A biorelevant and clinically relevant approach

European journal of pharmaceutics and biopharmaceutics, 2021-02, Vol.159, p.188-197

2021

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Dissolution media simulating the intralumenal composition of the small intestine: physiological issues and practical aspects

Journal of pharmacy and pharmacology, 2004-04, Vol.56 (4), p.453-462

2004

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In vitro versus canine data for predicting input profiles of isosorbide-5-mononitrate from oral extended release products on a confidence interval basis

European journal of pharmaceutical sciences, 2005, Vol.24 (1), p.115-122

2005

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In Vitro Drug Release Testing of Special Dosage Forms

Nikoletta Fotaki, Sandra Klein, Nikoletta Fotaki, Sandra Klein

First edition., 2019

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Biorelevant release testing of biodegradable microspheres intended for intra-articular administration

European journal of pharmaceutics and biopharmaceutics, 2019-06, Vol.139, p.115-122

2019

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Phase I clinical study to select a novel oral formulation for ibandronate containing the excipient sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC)

Pharmazie, 2012-03, Vol.67 (3), p.233-241

2012

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Age related biorelevant dissolution testing for paediatric formulations

International journal of pharmaceutics, 2018-02, Vol.536 (2), p.492-493

2018

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BU 08073 a buprenorphine analogue with partial agonist activity at μ‐receptors in vitro but long‐lasting opioid antagonist activity in vivo in mice

British journal of pharmacology, 2015-01, Vol.172 (2), p.668-680

2015

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Canine versus in vitro data for predicting input profiles of l-sulpiride after oral administration

European journal of pharmaceutical sciences, 2005-11, Vol.26 (3), p.324-333

2005

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Drug‐Eluting Stents

In Vitro Drug Release Testing of Special Dosage Forms, 2019, p.87-117

2019

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Vaginal and Intrauterine Delivery Systems

In Vitro Drug Release Testing of Special Dosage Forms, 2019, p.177-209

2019

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Ophthalmic Dosage Forms

In Vitro Drug Release Testing of Special Dosage Forms, 2019, p.235-251

2019

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Biopharmaceutical aspects and implications of excipient variability in drug product performance

BCS-based biowaivers: Extension to paediatrics

Surface dissolution UV imaging for characterization of superdisintegrants and their impact on drug dissolution

Impact of Food and Drink Administration Vehicles on Paediatric Formulation Performance: Part 1—Effects on Solubility of Poorly Soluble Drugs

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

Biopharmaceutical implications of excipient variability on drug dissolution from immediate release products

Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties: Case Study—Hypromellose (HPMC)

BU08073 a buprenorphine analogue with partial agonist activity at μ‐receptors in vitro but long‐lasting opioid antagonist activity in vivo in mice

An in vitro–in vivo correlation study for nifedipine immediate release capsules administered with water, alcoholic and non-alcoholic beverages: Impact of in vitro dissolution media and hydrodynamics

In vitro - in vivo relations for the parenteral liposomal formulation of Amphotericin B: A clinically relevant approach with PBPK modeling

Understanding and predicting the impact of critical dissolution variables for nifedipine immediate release capsules by multivariate data analysis

A comparative study of different release apparatus in generating in vitro– in vivo correlations for extended release formulations

Investigation and simulation of dissolution with concurrent degradation under healthy and hypoalbuminaemic simulated parenteral conditions- case example Amphotericin B

In vitro in vivo relations for the parenteral liposomal formulation of Amphotericin B: A biorelevant and clinically relevant approach

Dissolution media simulating the intralumenal composition of the small intestine: physiological issues and practical aspects

In vitro versus canine data for predicting input profiles of isosorbide-5-mononitrate from oral extended release products on a confidence interval basis

In Vitro Drug Release Testing of Special Dosage Forms

Biorelevant release testing of biodegradable microspheres intended for intra-articular administration

Phase I clinical study to select a novel oral formulation for ibandronate containing the excipient sodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC)

Age related biorelevant dissolution testing for paediatric formulations

BU 08073 a buprenorphine analogue with partial agonist activity at μ‐receptors in vitro but long‐lasting opioid antagonist activity in vivo in mice

Canine versus in vitro data for predicting input profiles of l-sulpiride after oral administration

Drug‐Eluting Stents

Vaginal and Intrauterine Delivery Systems

Ophthalmic Dosage Forms

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