Literature DB >> 31802399

Comment on: "Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?"

Patrick Nicolas1.   

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Year:  2020        PMID： 31802399     DOI： 10.1007/s40262-019-00849-y

Source DB:  PubMed          Journal:  Clin Pharmacokinet        ISSN： 0312-5963            Impact factor:   6.447


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  7 in total

1.  Connections between average and individual bioequivalence.

Authors:  A Munk
Journal:  Stat Med       Date:  2000-10-30       Impact factor: 2.373

2.  A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials.

Authors:  Yang Yu; Steven Teerenstra; Cees Neef; David Burger; Marc Maliepaard
Journal:  Br J Clin Pharmacol       Date:  2016-01-15       Impact factor: 4.335

3.  Comment on: "Levothyrox® New and Old Formulations: Are they Switchable for Millions of Patients?"

Authors:  Patrick Nicolas
Journal:  Clin Pharmacokinet       Date:  2019-07       Impact factor: 6.447

4.  New levothyroxine formulation meeting 95-105% specification over the whole shelf-life: results from two pharmacokinetic trials.

Authors:  Ulrike Gottwald-Hostalek; Wolfgang Uhl; Peter Wolna; George J Kahaly
Journal:  Curr Med Res Opin       Date:  2016-10-21       Impact factor: 2.580

5.  Bioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: a single-dose, randomized, open-label, crossover study.

Authors:  Guillermo Di Girolamo; Guillermo A Keller; Antonio R de Los Santos; Daniel Schere; Claudio D Gonzalez
Journal:  Clin Ther       Date:  2008-11       Impact factor: 3.393

6.  Pharmacokinetics and Comparative Bioavailability of a Levothyroxine Sodium Oral Solution and Soft Capsule.

Authors:  Mario Tanguay; Johanne Girard; Claudia Scarsi; Giuseppe Mautone; Richard Larouche
Journal:  Clin Pharmacol Drug Dev       Date:  2018-08-28

7.  Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?

Authors:  Didier Concordet; Peggy Gandia; Jean-Louis Montastruc; Alain Bousquet-Mélou; Peter Lees; Aude A Ferran; Pierre-Louis Toutain
Journal:  Clin Pharmacokinet       Date:  2020-01       Impact factor: 6.447
  7 in total

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