Standard curve range for clinical sample analysis of oral bioavailability/bioequivalence studies: dilemma, introspection and strategies

Prashant Tripathi; Harilal Patel; Tanuja Kulshrestha; Nuggehally R Srinivas

doi:10.4155/bio-2018-0008

Standard curve range for clinical sample analysis of oral bioavailability/bioequivalence studies: dilemma, introspection and strategies

Bioanalysis. 2018 May 1;10(10):717-722. doi: 10.4155/bio-2018-0008. Epub 2018 May 17.

Authors

Prashant Tripathi¹, Harilal Patel², Tanuja Kulshrestha¹, Nuggehally R Srinivas¹

Affiliations

¹ Corporate Research Quality Assurance, Sakhlej-Bavla NH No 8A, Moraiya, Ahmedabad 382 210, Gujarat, India.
² Bioanalytical Research and Drug Metabolism, Zydus Research Centre, Cadila Healthcare Ltd., Sakhlej-Bavla NH No 8A, Moraiya, Ahmedabad 382 210, Gujarat, India.

PMID: 29771145
DOI: 10.4155/bio-2018-0008

No abstract available

Keywords: bioanalysis; bioavailability & bioequivalence; dilution integrity; incurred sample reanalysis; peak concentration; pharmacokinetics; polymorphism; regulatory; small molecule; standard curve range; validation.

MeSH terms

Administration, Oral
Biological Availability
Calibration
Chemistry Techniques, Analytical / methods*
Drugs, Generic / administration & dosage
Drugs, Generic / pharmacokinetics*
Humans
Therapeutic Equivalency

Substances

Drugs, Generic