Literature DB >> 11032082

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.

R L Williams1, W Adams, M L Chen, D Hare, A Hussain, L Lesko, R Patnaik, V Shah.   

Abstract

Mesh：

Year:  2000        PMID： 11032082     DOI： 10.1007/BF03190049

Source DB:  PubMed          Journal:  Eur J Drug Metab Pharmacokinet        ISSN： 0378-7966            Impact factor:   2.441


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  14 in total

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

Authors:  G J Singh; W P Adams; L J Lesko; V P Shah; J A Molzon; R L Williams; L K Pershing
Journal:  Clin Pharmacol Ther       Date:  1999-10       Impact factor: 6.875

2.  An individual bioequivalence criterion: regulatory considerations.

Authors:  M L Chen; R Patnaik; W W Hauck; D J Schuirmann; T Hyslop; R Williams
Journal:  Stat Med       Date:  2000-10-30       Impact factor: 2.373

3.  An alternative approach for assessment of rate of absorption in bioequivalence studies.

Authors:  M L Chen
Journal:  Pharm Res       Date:  1992-11       Impact factor: 4.200

4.  The intellectual health of clinical drug evaluation.

Authors:  L B Sheiner
Journal:  Clin Pharmacol Ther       Date:  1991-07       Impact factor: 6.875

5.  Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence.

Authors:  L Endrenyi; S Fritsch; W Yan
Journal:  Int J Clin Pharmacol Ther Toxicol       Date:  1991-10

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

Authors:  T N Tozer; F Y Bois; W W Hauck; M L Chen; R L Williams
Journal:  Pharm Res       Date:  1996-03       Impact factor: 4.200

7.  The duration of measuring partial AUCs for the assessment of bioequivalence.

Authors:  L Endrenyi; F Csizmadia; L Tothfalusi; A H Balch; M L Chen
Journal:  Pharm Res       Date:  1998-03       Impact factor: 4.200

8.  Evaluation of different indirect measures of rate of drug absorption in comparative pharmacokinetic studies.

Authors:  L F Lacey; O N Keene; C Duquesnoy; A Bye
Journal:  J Pharm Sci       Date:  1994-02       Impact factor: 3.534

9.  Bioequivalence: performance of several measures of rate of absorption.

Authors:  F Y Bois; T N Tozer; W W Hauck; M L Chen; R Patnaik; R L Williams
Journal:  Pharm Res       Date:  1994-07       Impact factor: 4.200

10.  Without extrapolation, Cmax/AUC is an effective metric in investigations of bioequivalence.

Authors:  L Tothfalusi; L Endrenyi
Journal:  Pharm Res       Date:  1995-06       Impact factor: 4.200
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  3 in total

Review 1.  Bioavailability and bioequivalence: an FDA regulatory overview.

Authors:  M L Chen; V Shah; R Patnaik; W Adams; A Hussain; D Conner; M Mehta; H Malinowski; J Lazor; S M Huang; D Hare; L Lesko; D Sporn; R Williams
Journal:  Pharm Res       Date:  2001-12       Impact factor: 4.200

Review 2.  Content uniformity and dose uniformity: current approaches, statistical analyses, and presentation of an alternative approach, with special reference to oral inhalation and nasal drug products.

Authors:  Roger L Williams; Wallace P Adams; Guirag Poochikian; Walter W Hauck
Journal:  Pharm Res       Date:  2002-04       Impact factor: 4.200

3.  Study of the applicabilty of content uniformity and dissolution variation test on ropinirole hydrochloride tablets.

Authors:  Edina Vranić; Alija Uzunović
Journal:  Bosn J Basic Med Sci       Date:  2008-05       Impact factor: 3.363
  3 in total

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