Literature DB >> 19806461

Bioequivalence; its history, practice, and future.

Kamal K Midha, Gordon McKay.   

Abstract

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Year:  2009        PMID： 19806461      PMCID： PMC2782076          DOI： 10.1208/s12248-009-9142-z

Source DB:  PubMed          Journal:  AAPS J        ISSN： 1550-7416            Impact factor:   4.009


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  12 in total

Review 1.  The role of metabolites in bioequivalence.

Authors:  Kamal K Midha; Maureen J Rawson; John W Hubbard
Journal:  Pharm Res       Date:  2004-08       Impact factor: 4.200

2.  Conference report: Bio-International 2005.

Authors:  Kamal K Midha; Vinod P Shah; Gur Jai Pal Singh; Rabi Patnaik
Journal:  J Pharm Sci       Date:  2007-04       Impact factor: 3.534

Review 3.  Bioequivalence approaches for highly variable drugs and drug products.

Authors:  Sam H Haidar; Barbara Davit; Mei-Ling Chen; Dale Conner; LaiMing Lee; Qian H Li; Robert Lionberger; Fairouz Makhlouf; Devvrat Patel; Donald J Schuirmann; Lawrence X Yu
Journal:  Pharm Res       Date:  2007-09-22       Impact factor: 4.200

4.  A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability.

Authors:  D J Schuirmann
Journal:  J Pharmacokinet Biopharm       Date:  1987-12

5.  Generic drugs and the prescribing physician.

Authors:  S L Nightingale; J C Morrison
Journal:  JAMA       Date:  1987-09-04       Impact factor: 56.272

6.  Use of confidence intervals in analysis of comparative bioavailability trials.

Authors:  W J Westlake
Journal:  J Pharm Sci       Date:  1972-08       Impact factor: 3.534

7.  Comparison of different methods for decision-making in bioequivalence assessment.

Authors:  D Mandallaz; J Mau
Journal:  Biometrics       Date:  1981-06       Impact factor: 2.571

8.  Determining the probability of an important difference in bioavailability.

Authors:  B E Rodda; R L Davis
Journal:  Clin Pharmacol Ther       Date:  1980-08       Impact factor: 6.875

9.  Patients' perceptions of generic medications.

Authors:  William H Shrank; Emily R Cox; Michael A Fischer; Jyotsna Mehta; Niteesh K Choudhry
Journal:  Health Aff (Millwood)       Date:  2009 Mar-Apr       Impact factor: 6.301

10.  Generic products of antiepileptic drugs (AEDs): is it an issue?

Authors:  Meir Bialer
Journal:  Epilepsia       Date:  2007-09-10       Impact factor: 5.864
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  20 in total

1.  Informational needs for participation in bioequivalence studies: the perspectives of experienced volunteers.

Authors:  Nut Koonrungsesomboon; Saranyapin Potikanond; Mingkwan Na Takuathung; Wutigri Nimlamool; Juntra Karbwang
Journal:  Eur J Clin Pharmacol       Date:  2019-08-19       Impact factor: 2.953

Review 2.  Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada.

Authors:  Upendra C Galgatte; Vijay R Jamdade; Pravin P Aute; Pravin D Chaudhari
Journal:  Saudi Pharm J       Date:  2013-05-31       Impact factor: 4.330

3.  Statistical comparison of dissolution profiles to predict the bioequivalence of extended release formulations.

Authors:  J D Gomez-Mantilla; U F Schaefer; V G Casabo; T Lehr; C M Lehr
Journal:  AAPS J       Date:  2014-05-23       Impact factor: 4.009

4.  Acarbose bioequivalence: exploration of new pharmacodynamic parameters.

Authors:  Min Zhang; Jin Yang; Lei Tao; Lingjun Li; Pengcheng Ma; John Paul Fawcett
Journal:  AAPS J       Date:  2012-03-15       Impact factor: 4.009

5.  Untangling Absorption Mechanisms and Variability in Bioequivalence Studies Using Population Analysis.

Authors:  Carolina Ameijeiras Rodríguez; Sara Carolina Henriques; Aymara Sancho-Araiz; Iñaki F Trocóniz; Luis Almeida; Nuno Elvas Silva
Journal:  Pharm Res       Date:  2021-12-21       Impact factor: 4.200

6.  Data mining methodology for response to hypertension symptomology-application to COVID-19-related pharmacovigilance.

Authors:  Xuan Xu; Jessica Kawakami; Nuwan Indika Millagaha Gedara; Jim E Riviere; Emma Meyer; Gerald J Wyckoff; Majid Jaberi-Douraki
Journal:  Elife       Date:  2021-11-23       Impact factor: 8.140

7.  Multivariate Assessment for Bioequivalence Based on the Correlation of Random Effect.

Authors:  Hyungmi An; Dongseong Shin
Journal:  Drug Des Devel Ther       Date:  2021-08-23       Impact factor: 4.162

8.  Web-based assessments of physical activity in youth: considerations for design and scale calibration.

Authors:  Pedro F Saint-Maurice; Gregory J Welk
Journal:  J Med Internet Res       Date:  2014-12-01       Impact factor: 5.428

9.  Bioequivalence of eslicarbazepine acetate from two different sources of its active product ingredient in healthy subjects.

Authors:  Amílcar Falcão; Ricardo Lima; Rui Sousa; Teresa Nunes; Patrício Soares-da-Silva
Journal:  Drugs R D       Date:  2013-06

10.  Differences in the rheological properties and mixing compatibility with heparinoid cream of brand name and generic steroidal ointments: The effects of their surfactants.

Authors:  Shuji Kitagawa; Reiko Yutani; Rhu-Ichi Kodani; Reiko Teraoka
Journal:  Results Pharma Sci       Date:  2016-02-13
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