Literature DB >> 11303967

Bioanalytical method validation--a revisit with a decade of progress.

V P Shah1, K K Midha, J W Findlay, H M Hill, J D Hulse, I J McGilveray, G McKay, K J Miller, R N Patnaik, M L Powell, A Tonelli, C T Viswanathan, A Yacobi.   

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Year:  2000        PMID： 11303967     DOI： 10.1023/a:1007669411738

Source DB:  PubMed          Journal:  Pharm Res        ISSN： 0724-8741            Impact factor:   4.200


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  6 in total

1.  Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective.

Authors:  J W Findlay; W C Smith; J W Lee; G D Nordblom; I Das; B S DeSilva; M N Khan; R R Bowsher
Journal:  J Pharm Biomed Anal       Date:  2000-01       Impact factor: 3.935

2.  Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report.

Authors:  V P Shah; K K Midha; S Dighe; I J McGilveray; J P Skelly; A Yacobi; T Layloff; C T Viswanathan; C E Cook; R D McDowall
Journal:  Eur J Drug Metab Pharmacokinet       Date:  1991 Oct-Dec       Impact factor: 2.441

Review 3.  Validation of bioanalytical methods.

Authors:  H T Karnes; G Shiu; V P Shah
Journal:  Pharm Res       Date:  1991-04       Impact factor: 4.200

4.  Rational experimental design for bioanalytical methods validation. Illustration using an assay method for total captopril in plasma.

Authors:  J Wieling; G Hendriks; W J Tamminga; J Hempenius; C K Mensink; B Oosterhuis; J H Jonkman
Journal:  J Chromatogr A       Date:  1996-04-12       Impact factor: 4.759

Review 5.  Validation of bioanalytical chromatographic methods.

Authors:  C Hartmann; J Smeyers-Verbeke; D L Massart; R D McDowall
Journal:  J Pharm Biomed Anal       Date:  1998-06       Impact factor: 3.935

6.  An assessment of the 4-6-20 rule for acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies.

Authors:  R O Kringle
Journal:  Pharm Res       Date:  1994-04       Impact factor: 4.200
  6 in total
  194 in total

1.  Lymphatic absorption is a significant contributor to the subcutaneous bioavailability of insulin in a sheep model.

Authors:  S A Charman; D N McLennan; G A Edwards; C J Porter
Journal:  Pharm Res       Date:  2001-11       Impact factor: 4.200

2.  An extended point-area deconvolution approach for assessing drug input rates.

Authors:  K C Yeh; D J Holder; G A Winchell; L A Wenning; T Prueksaritanont
Journal:  Pharm Res       Date:  2001-10       Impact factor: 4.200

3.  Ultra-performance liquid chromatography mass spectrometry and sensitive bioassay methods for quantification of posaconazole plasma concentrations after oral dosing.

Authors:  Bertrand Rochat; Andres Pascual; Benoît Pesse; Frédéric Lamoth; Dominique Sanglard; Laurent A Decosterd; Jacques Bille; Oscar Marchetti
Journal:  Antimicrob Agents Chemother       Date:  2010-10-04       Impact factor: 5.191

4.  Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.

Authors:  Binodh DeSilva; Wendell Smith; Russell Weiner; Marian Kelley; JoMarie Smolec; Ben Lee; Masood Khan; Richard Tacey; Howard Hill; Abbie Celniker
Journal:  Pharm Res       Date:  2003-11       Impact factor: 4.200

Review 5.  Biomarkers, validation and pharmacokinetic-pharmacodynamic modelling.

Authors:  Wayne A Colburn; Jean W Lee
Journal:  Clin Pharmacokinet       Date:  2003       Impact factor: 6.447

6.  Qualification of analytical instruments for use in the pharmaceutical industry: a scientific approach.

Authors:  Surendra K Bansal; Thomas Layloff; Ernest D Bush; Marta Hamilton; Edward A Hankinson; John S Landy; Stephen Lowes; Moheb M Nasr; Paul A St Jean; Vinod P Shah
Journal:  AAPS PharmSciTech       Date:  2004-04-02       Impact factor: 3.246

7.  Quantitative analysis of therapeutic drugs in dried blood spot samples by paper spray mass spectrometry: an avenue to therapeutic drug monitoring.

Authors:  Nicholas Edward Manicke; Paul Abu-Rabie; Neil Spooner; Zheng Ouyang; R Graham Cooks
Journal:  J Am Soc Mass Spectrom       Date:  2011-06-21       Impact factor: 3.109

8.  Multiplex ultra-performance liquid chromatography-tandem mass spectrometry method for simultaneous quantification in human plasma of fluconazole, itraconazole, hydroxyitraconazole, posaconazole, voriconazole, voriconazole-N-oxide, anidulafungin, and caspofungin.

Authors:  Laurent Arthur Decosterd; Bertrand Rochat; Benoît Pesse; Thomas Mercier; Frédéric Tissot; Nicolas Widmer; Jacques Bille; Thierry Calandra; Boris Zanolari; Oscar Marchetti
Journal:  Antimicrob Agents Chemother       Date:  2010-09-20       Impact factor: 5.191

9.  Accessible Telemedicine Diagnostics with ELISA in a 3D Printed Pipette Tip.

Authors:  Mohamed Sharafeldin; Karteek Kadimisetty; Ketki R Bhalerao; Itti Bist; Abby Jones; Tianqi Chen; Norman H Lee; James F Rusling
Journal:  Anal Chem       Date:  2019-05-14       Impact factor: 6.986

10.  Lack of pharmacokinetic interaction of mipomersen sodium (ISIS 301012), a 2'-O-methoxyethyl modified antisense oligonucleotide targeting apolipoprotein B-100 messenger RNA, with simvastatin and ezetimibe.

Authors:  Rosie Z Yu; Richard S Geary; Joann D Flaim; Gina C Riley; Diane L Tribble; André A vanVliet; Mark K Wedel
Journal:  Clin Pharmacokinet       Date:  2009       Impact factor: 6.447
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