(Q37150863)

18 August 2017

1 reference

title

FDA critical path initiatives: opportunities for generic drug development (English)

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18 August 2017

1

Robert A Lionberger

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PMCID

2751455

18 August 2017

language of work or name

English

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publication date

20 February 2008

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18 August 2017

7

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inferred from page(s)

published in

The AAPS Journal

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18 August 2017

10

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18 August 2017

1

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18 August 2017

103-109

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https://scigraph.springernature.com/pub.10.1208/s12248-008-9010-2

18 August 2017

0 references

cites work

Particle size analysis in pharmaceutics: principles, methods and applications

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Effects of corticosteroids on noninvasive biomarkers of inflammation in asthma and chronic obstructive pulmonary disease

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Assessment of cutaneous drug delivery using microdialysis

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Bioavailability and bioequivalence: an FDA regulatory overview

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Assessment of topical bioavailability in vivo: the importance of stratum corneum thickness

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Microdialysis for the evaluation of penetration through the human skin barrier - a promising tool for future research?

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Forecasting the in vivo performance of four low solubility drugs from their in vitro dissolution data

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Analysis of chromameter results obtained from corticosteroid-induced skin blanching. I: Manipulation of data.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Characterization of the permeability barrier of human skin in vivo

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

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

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

New approaches to assess topical corticosteroid bioequivalence: pharmacokinetic evaluation

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Non-inferiority testing with a variable margin.

27 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

The influence of inhaled corticosteroids on exhaled nitric oxide in stable chronic obstructive pulmonary disease.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Comparison of skin stripping, in vitro release, and skin blanching response methods to measure dose response and similarity of triamcinolone acetonide cream strengths from two manufactured sources

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Asthma stability after oral prednisone: a clinical model for comparing inhaled steroid potency

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Supersaturation: enhancement of skin penetration and permeation of a lipophilic drug.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamics.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Dose-response relationship and reproducibility of the fall in exhaled nitric oxide after inhaled beclomethasone dipropionate therapy in asthma patients

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Physical and physiological effects of stratum corneum tape stripping

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2751455

Dose-response evaluation of the therapeutic index for inhaled budesonide in patients with mild-to-moderate asthma

3 September 2018

1 reference

12 December 2020

Equivalence concepts in clinical trials

1 reference

12 December 2020

Clinical investigators--the endangered species revisited

1 reference

12 December 2020

Progress in methodologies for evaluating bioequivalence of topical formulations

1 reference

12 December 2020

Non-inferiority trials: the 'at least as good as' criterion

1 reference

12 December 2020

Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities

1 reference

12 December 2020

A method for predicting steady-state rate of skin penetration in vivo

1 reference

12 December 2020

Topical 0.050% betamethasone dipropionate. Pharmacokinetic and pharmacodynamic dose-response studies in humans

1 reference

12 December 2020

10.1208/S12248-008-9010-2

Identifiers

DOI

1 reference

PMCID

2751455

Dimensions Publication ID

18 August 2017

0 references

1 reference

18 August 2017

1 reference

PMCID

2751455