(Q41820962)

12 October 2017

Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds (English)

1 reference

12 October 2017

Marija Tubic-Grozdanis

series ordinal

1

1 reference

12 October 2017

Michael B Bolger

series ordinal

2

1 reference

12 October 2017

Peter Langguth

series ordinal

3

1 reference

12 October 2017

language of work or name

English

0 references

publication date

2 April 2008

1 reference

12 October 2017

1 reference

12 October 2017

10

1 reference

12 October 2017

1

1 reference

12 October 2017

213-226

1 reference

Biowaiver monographs for immediate release solid oral dosage forms: prednisolone

12 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Anti-inflammatory, antipyretic and antinociceptive properties of N-(2,3-xylyl)anthranilic acid (mefenamic acid).

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Clinical relevance of bioequivalence acceptance criteria. The example of terbinafine

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

The composite solubility versus pH profile and its role in intestinal absorption prediction

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Predicting the impact of physiological and biochemical processes on oral drug bioavailability

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Clinical pharmacokinetics of ibuprofen. The first 30 years

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Effects of an acidic beverage (Coca-Cola) on absorption of ketoconazole

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Dose dependent pharmacokinetics of prednisone and prednisolone in man

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Piroxicam. A reappraisal of its pharmacology and therapeutic efficacy

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Ketoprofen: a review of its pharmacologic and clinical properties

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Pharmacokinetics of ketoprofen enantiomers in healthy subjects following single and multiple doses

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

The mechanism of action of terbinafine

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Clinical pharmacokinetics of terbinafine (Lamisil).

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Clinical pharmacokinetics of ketoprofen and its enantiomers

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Bioequivalence of two formulations of piroxicam

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Miconazole: a review of its antifungal activity and therapeutic efficacy

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Clinical Pharmacokinetics of Propranolol

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Estimation of intragastric solubility of drugs: in what medium?

6 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Rapid in vivo dissolution of ketoprofen: implications on the biopharmaceutics classification system.

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

The effect of food on the relative bioavailability of rapidly dissolving immediate-release solid oral products containing highly soluble drugs

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Molecular properties of WHO essential drugs and provisional biopharmaceutical classification

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

pH-dependent dissolution in vitro and absorption in vivo of weakly basic drugs: development of a canine model

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Comparison of a miniaturized shake-flask solubility method with automated potentiometric acid/base titrations and calculated solubilities

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Identification of biowaivers among Class II drugs: theoretical justification and practical examples.

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Gastric function in the elderly: effects on absorption of ketoconazole

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Pharmacokinetics of two oral prednisolone tablet formulations in healthy volunteers

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Bioequivalence of different prednisolone tablet formulations

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Preparation and characterisation of a range of diclofenac salts

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

Dissolution properties of piroxicam powders and capsules as a function of particle size and the agglomeration of powders

18 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751468

[Pharmacokinetics and bioequivalence of two ibuprofen formulations]

18 August 2018

1 reference

12 December 2020

Comparative bioavailability of two tablet formulations of diclofenac sodium in normal subjects

1 reference

12 December 2020

Solubility of mefenamic acid under simulated fed- and fasted-state conditions

1 reference

12 December 2020

Identification of P450 enzymes involved in metabolism of verapamil in humans

1 reference

12 December 2020

Intrasubject variability in bioequivalence studies illustrated by the example of ibuprofen

1 reference

12 December 2020

High variability in drug pharmacokinetics complicates determination of bioequivalence: experience with verapamil

1 reference

12 December 2020

Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate-release tablet formulations

1 reference

12 December 2020

Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs

1 reference

12 December 2020

When are bioavailability studies required? A German proposal

1 reference

12 December 2020

Pharmacokinetics and protein binding of prednisolone after oral and intravenous administration

1 reference

12 December 2020

Dose-dependent elimination of propranolol and its major metabolites in humans

1 reference

12 December 2020

Effect of pH on disintegration and dissolution of ketoconazole tablets

1 reference

12 December 2020

Solubilization and dissolution of insoluble weak acid, ketoprofen: effects of pH combined with surfactant

1 reference

12 December 2020

The suitability of an in situ perfusion model for permeability determinations: utility for BCS class I biowaiver requests

1 reference

12 December 2020

Pharmacokinetic simulation of biowaiver criteria: the effects of gastric emptying, dissolution, absorption and elimination rates

1 reference

12 December 2020

When do differences in dissolution profiles predict clinical problems?

1 reference

12 December 2020

Biopharmaceutics classification system: the scientific basis for biowaiver extensions

1 reference

12 December 2020

10.1208/S12248-008-9023-X

Identifiers

DOI

1 reference

Dimensions Publication ID

12 October 2017

0 references

1 reference

12 October 2017

PubMed publication ID

18446522

1 reference