In vitro bioequivalence testing

2002 ◽  
Vol 22 (1) ◽  
pp. 55-68 ◽  
Author(s):  
Shein-Chung Chow ◽  
Jun Shao ◽  
Hansheng Wang
Keyword(s):  
Bioequivalence Testing

In Vitro Bioequivalence Testing

2003 ◽  
pp. 449-455 ◽  
Author(s):  
Hansheng Wang ◽  
Ying Zhang ◽  
Jun Shao
Keyword(s):  
Bioequivalence Testing

scholarly journals Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability

2021 ◽  
Vol 22 (7) ◽  
Author(s):  
Elise Burmeister Getz ◽  
Kevin J. Carroll ◽  
J. David Christopher ◽  
Beth Morgan ◽  
Scott Haughie ◽  
...  
Keyword(s):  
Type I Error ◽  
Random Effect ◽  
Batch Effect ◽  
Type I ◽  
Drug Products ◽  
Orally Inhaled Drug Products ◽  
Bioequivalence Testing ◽  
Study Participants ◽  
Single Batch

AbstractBatch-to-batch pharmacokinetic (PK) variability of orally inhaled drug products has been documented and can render single-batch PK bioequivalence (BE) studies unreliable; results from one batch may not be consistent with a repeated study using a different batch, yet the goal of PK BE is to deliver a product comparison that is interpretable beyond the specific batches used in the study. We characterized four multiple-batch PK BE approaches to improve outcome reliability without increasing the number of clinical study participants. Three approaches include multiple batches directly in the PK BE study with batch identity either excluded from the statistical model (“Superbatch”) or included as a fixed or random effect (“Fixed Batch Effect,” “Random Batch Effect”). A fourth approach uses a bio-predictive in vitro test to screen candidate batches, bringing the median batch of each product into the PK BE study (“Targeted Batch”). Three of these approaches (Fixed Batch Effect, Superbatch, Targeted Batch) continue the single-batch PK BE convention in which uncertainty in the Test/Reference ratio estimate due to batch sampling is omitted from the Test/Reference confidence interval. All three of these approaches provided higher power to correctly identify true bioequivalence than the standard single-batch approach with no increase in clinical burden. False equivalence (type I) error was inflated above the expected 5% level, but multiple batches controlled type I error better than a single batch. The Random Batch Effect approach restored 5% type I error, but had low power for small (e.g., <8) batch sample sizes using standard [0.8000, 1.2500] bioequivalence limits.

In Vitro Bioequivalence Testing

2012 ◽  
pp. 614-619
Author(s):  
Hansheng Wang ◽  
Ying Zhang ◽  
Jun Shao
Keyword(s):  
Bioequivalence Testing

Batch Selection via In Vitro/In Vivo Correlation in Pharmacokinetic Bioequivalence Testing

2021 ◽  
Vol 22 (7) ◽  
Author(s):  
Elise Burmeister Getz ◽  
Kevin J. Carroll ◽  
Johanna Mielke ◽  
Byron Jones ◽  
Leslie Z. Benet
Keyword(s):  
Bioequivalence Testing

scholarly journals STABILITY INDICATING SPECTROPHOTOMETRIC METHODS OF NELFINAVIR AND THEIR APPLICATION TO IN-VITRO BIOEQUIVALENCE TESTING

2013 ◽  
Vol 2 (5) ◽  
pp. 29-33
Author(s):  
Fathi H Assaleh ◽  
Shanta Kumari Adiki ◽  
Shaban G Elosta ◽  
Fathi M Asseid ◽  
Prakash Katakam ◽  
...  
Keyword(s):  
Stability Indicating ◽  
Spectrophotometric Methods ◽  
Bioequivalence Testing

Ultrastructural Investigations of the Contractile Filaments of Amoebae

1974 ◽  
Vol 32 ◽  
pp. 188-189
Author(s):  
P.L. Moore
Keyword(s):  
Cytoplasmic Streaming ◽  
Three Dimensional ◽  
Freeze Fracture ◽  
Amoeboid Movement ◽  
Different Types ◽  
Chemical Conditions ◽  
Complete Interpretation

Previous freeze fracture results on the intact giant, amoeba Chaos carolinensis indicated the presence of a fibrillar arrangement of filaments within the cytoplasm. A complete interpretation of the three dimensional ultrastructure of these structures, and their possible role in amoeboid movement was not possible, since comparable results could not be obtained with conventional fixation of intact amoebae. Progress in interpreting the freeze fracture images of amoebae required a more thorough understanding of the different types of filaments present in amoebae, and of the ways in which they could be organized while remaining functional.The recent development of a calcium sensitive, demembranated, amoeboid model of Chaos carolinensis has made it possible to achieve a better understanding of such functional arrangements of amoeboid filaments. In these models the motility of demembranated cytoplasm can be controlled in vitro, and the chemical conditions necessary for contractility, and cytoplasmic streaming can be investigated. It is clear from these studies that “fibrils” exist in amoeboid models, and that they are capable of contracting along their length under conditions similar to those which cause contraction in vertebrate muscles.

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