(Q34489341)

English

Bioavailability and bioequivalence: an FDA regulatory overview

scientific article

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Statements

scholarly article

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

1 reference

Europe PubMed Central

Bioavailability and bioequivalence: an FDA regulatory overview (English)

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

bioavailability

1 reference

based on heuristic

inferred from title

author name string

Chen ML

1

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Shah V

2

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Patnaik R

3

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Adams W

4

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Hussain A

5

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Conner D

6

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Mehta M

7

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Malinowski H

8

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Lazor J

9

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Huang SM

10

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Hare D

11

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Lesko L

12

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Sporn D

13

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Williams R

14

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

publication date

1 December 2001

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Pharmaceutical Research

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Europe PubMed Central

PubMed publication ID

2 August 2017

18

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Europe PubMed Central

PubMed publication ID

2 August 2017

12

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

1645-1650

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? FDA Biopharmaceutics Coordinating Committee

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Absorption rate vs. exposure: which is more useful for bioequivalence testing?

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

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

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Measures of exposure versus measures of rate and extent of absorption

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

An individual bioequivalence criterion: regulatory considerations

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Comparison of single and multiple dose pharmacokinetics using clinical bioequivalence data and Monte Carlo simulations

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Evaluation of bioequivalence of highly variable drugs using Monte Carlo simulations. I. Estimation of rate of absorption for single and multiple dose trials using Cmax

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Standardized challenge testing with pharmacological, physical and sensitizing stimuli in adults

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Evaluation of bioequivalence of highly variable drugs using clinical trial simulations. II: Comparison of single and multiple-dose trials using AUC and Cmax

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Learning versus confirming in clinical drug development

1 reference

https://pubmed.ncbi.nlm.nih.gov/11785681

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Identifiers

10.1023/A:1013319408893

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

PubMed publication ID

1 reference

Europe PubMed Central

PubMed publication ID

2 August 2017

ResearchGate publication ID

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