Relevant bibliographies by topics / Bioequivalence

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Bioequivalence'

Author: Grafiati
Published: 4 June 2021
Last updated: 25 July 2025

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Journal articles on the topic "Bioequivalence"

1

Balthasar, Joseph P. "Bioequivalence and Bioequivalency Testing." American Journal of Pharmaceutical Education 63, no. 2 (1999): 194–98. http://dx.doi.org/10.1016/s0002-9459(24)01740-6.

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Micheal, Francis, Mohanlal Sayana, Rajendra Prasad, and Balamurali Musuvathi Motilal. "Has the Time Come to Employ Population and Individual Bioequivalence for the Evaluation of Generics?" Current Drug Metabolism 21, no. 2 (2020): 112–25. http://dx.doi.org/10.2174/1389200221666200401105119.

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Background: Bioequivalence studies are a vital part of drug development. The average bioequivalence approach is the standard method of assessment to conclude whether the generic product is bioequivalent to the innovator product. Of late, debates are on whether the average bioequivalence approach adequately addresses drug interchangeability as it considers only population mean for the evaluation especially when highly variable drug products and narrow therapeutic index drugs are dealt with. Hence, the alternative approaches like population bioequivalence and individual bioequivalence assessment
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Blier, Pierre. "Generic Substitution for Psychotropic Drugs." CNS Spectrums 14, no. 9 (2009): 1–7. http://dx.doi.org/10.1017/s1092852900024706.

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Most antidepressants and other psychotropics in clinical use are available as generic formulations (Table). The availability of lower-priced, generic drugs can benefit patients and third-party payers, but it should not be assumed that all generic drugs are equally beneficial. There are numerous reports in the literature of unexpected and untoward consequences that occur when a generic drug is substituted for the original brand-name drug. A previously stable clinical response may suddenly deteriorate, or the patient may experience new or more severe adverse events (AEs). The United States Food
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Ozdin, Deniz, Murray P. Ducharme, France Varin, Anders Fuglsang, and Dina Al-Numani. "Influence of Different Populations on Pharmacokinetic Bioequivalence Results: Can We Extrapolate Bioequivalence Results from One Population to Another?" Journal of Pharmacy & Pharmaceutical Sciences 23 (October 14, 2020): 357–88. http://dx.doi.org/10.18433/jpps30872.

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Purpose: Over the last 15 years, an ever-increasing proportion of pharmacokinetic bioequivalence studies for European/North American generic submissions appeared to have been conducted in geographical/ethnic populations other than those for which the drug is marketed for. The results of pharmacokinetic bioequivalence studies have traditionally been considered to be insensitive to the population studied. However, several recent studies have suggested that this may not necessarily be true. The objective of this study was to investigate whether there were any concerns regarding the current practi
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Khokhlov, A. L., A. A. Khokhlov, A. E. Miroshnikov, O. V. Lebedeva, and D. Yu Grebenkin. "Pharmacokinetic and bioequivalence study of Telzap® in comparison with Mikardis® in healthy subjects after single administrationl." Pharmacokinetics and Pharmacodynamics, no. 4 (January 19, 2023): 62–68. http://dx.doi.org/10.37489/2587-7836-2022-4-62-68.

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Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of Mikardis® (telmisartan, tablets 80 mg, Boehringer Ingelheim International GmbH, Germany) and Telzap® (telmisartan, tablets 80 mg, Zentiva KS company, Czech Republic) in healthy volunteers after a single ad
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Li, Jianghao, and Shein-Chung Chow. "Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability." Journal of Probability and Statistics 2015 (2015): 1–13. http://dx.doi.org/10.1155/2015/298647.

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For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequivalence in terms of drug absorption be provided through the conduct of a bioequivalence study. A test product is said to be average bioequivalent to a reference (innovative) product if the 90% confidence interval of the ratio of means (after log-transformation) is totally within (80%, 125%). This approach is considered a one-parameter approach, which does not account for possible heterogeneity of variability between drug products. In this paper, we study a two-parameter approach (i.e., confidence
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Kubesh, V., A. L. Khokhlov, A. M. Shitova, et al. "Pharmacokinetic and Bioequivalence Study of Telzap AM® (Telmisartan/amlodipine Fixed-dose Combination) and Coadministered Mikardis® (Telmisartan) and Norvask® (Amlodipine) in Healthy Subjects." Drug development & registration 9, no. 4 (2020): 155–63. http://dx.doi.org/10.33380/2305-2066-2020-9-4-155-163.

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Introduction. A fixed dose combination of telmisartan and amlodipine is widely used in clinical practice during hypertension treatment. Combination of telmisartan and amlodipine demonstrates potentiating synergistic effect on blood pressure decrease. A bioequivalence study of Telzap® AM with coadministered Mikardis® and Norvask® was conducted with 60 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of the fixed dose combination drug product Telzap® AM (telmisartan + amlodipine, tablets, 80 + 10 mg, Zentiv
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Khokhlov, A. L., A. A. Khokhlov, A. E. Miroshnikov, O. V. Lebedeva, and D. Yu Grebenkin. "Pharmacokinetic and bioequivalence study of Telzap® Plus fixed-dose combination compared with MikardisPlus® in healthy volunteers after single administration." Pharmacokinetics and Pharmacodynamics, no. 4 (January 19, 2023): 69–77. http://dx.doi.org/10.37489/2587-7836-2022-4-69-77.

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Introduction. A fixed dose combination of telmisartan and hydrochlorothiazide is indicated for treatment of in the treatment of arterial hypertension. The combination of these substances causes an additive effect that helps to reduce blood pressure. A bioequivalence study of Telzap® Plus compared with MikardisPlus® was conducted with 63 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of the fixed dose combination drug product Telzap® Plus (tablets 80 mg + 12,5 mg, Zentiva KS company, Czech Republic) comp
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Hamrell, Michael R., Marilyn N. Martinez, Shrikant V. Dighe, and Paul D. Parkman. "Bioequivalence of Generic Thioridazine Drug Products—The FDA Viewpoint." Drug Intelligence & Clinical Pharmacy 21, no. 4 (1987): 362–69. http://dx.doi.org/10.1177/106002808702100413.

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The phenothiazines are among the most widely used drugs to treat symptoms commonly associated with acute and chronic psychoses. One of the commonly prescribed compounds within this class of drugs is thioridazine, available both as a generic product as well as the innovator product, Mellaril. Each of these products is coded as bioequivalent and consequently therapeutically equivalent by the Food and Drug Administration (FDA). A recent issue of this journal contained an article that raised a number of questions concerning the bioequivalence of the generic versions of thioridazine that have been
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Kim, Suyoung, HyunYoung Chae, Eon-Bee Lee, Gayeong Lee, Seung-Chun Park, and Jeongwoo Kang. "Comparative Pharmacokinetics and Bioequivalence of Pour-On Ivermectin Formulations in Korean Hanwoo Cattle." Antibiotics 13, no. 1 (2023): 3. http://dx.doi.org/10.3390/antibiotics13010003.

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This study aimed to conduct a bioequivalence study of applying three pour-on ivermectin formulations at a dose of 1 mg/kg on the back of Korean native beef cattle (Hanwoo). To conduct bioequivalence testing, the pharmacokinetics of three groups (control Innovator, test Generic A, and test Generic B) of five clinically healthy Korean Hanwoo cattle (average weight 500 kg) were studied. After topical application to the skin, blood samples were drawn at the indicated times. These blood samples were analyzed using liquid chromatography–tandem mass spectrometry (LC-MS/MS). The time required to reach
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Dissertations / Theses on the topic "Bioequivalence"

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Montague, Timothy H. "Adaptive designs for bioequivalence trails." Thesis, University of Reading, 2007. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.494779.

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In recent years, there has been a growing interest within the medical research community in the application of adaptive designs in drug development. One potential application of adaptive designs is for bioequivalence trials, as they provide a means for managing the uncertainty around the anticipated variance to be used to power the study. If the anticipated variance is less than the true variance, the study may be under-powered resulting in the inability to demonstrate bioequivalence. Adaptive designs which allow one to both stop for success or futility at the interim or re-estimate the sample
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Purkiss, Ronald. "Bioequivalence of sustained release theophylline formulations." Thesis, Aston University, 1986. http://publications.aston.ac.uk/12472/.

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The bioequivalence of sustained release theophylline formulations, marketed in the United Kingdom, has been investigated in relation to the co-administration of food in both single dose and steady state volunteer studies. The effect of food on pharmacokinetic parameters and their clinical relevance was researched. Experimentation using drug induced modification of gastric motility to ascertain the component influences of the rate of gastric emptying on the absorption of theophylline from sustained release formulations was conducted. Prolongation of time to maximum plasma theophylline concentra
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Bersbach, Brian. "Comparison of Levothyroxine Bioequivalence Between Products." The University of Arizona, 2006. http://hdl.handle.net/10150/624663.

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Class of 2006 Abstract<br>Background: Approximately 2% of the population has hypothyroidism, and are treated with a levothyroxine product. Unlike other medications, levothyroxine products have not been considered substitutable due to their narrow therapeutic window. Objectives: To compare the bioequivalence study findings from studies conducted by the manufacturer of Synthroid to those conducted by other investigators. Methods: Studies comparing levothyroxine product bioequivalence were found and divided according to time period, study design, and major funding party. Results: Ten studies
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ALY, SAID. "Progres en bioequivalence et quelques problemes lies." Paris 6, 1990. http://www.theses.fr/1990PA066015.

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La decision de bioequivalence entre deux (ou plusieurs) formulations d'un meme medicament, issues d'un meme fabriquant ou non, est devenue indispensable dans le domaine medical en pharmaceutique. Les definitions et les suppositions de bioequivalence ainsi que leur comprehension dans les essais comparatifs de biodisponibilite et les essais cliniques d'efficacite sont introduites dans le chapitre 1. La similarite des courbes de concentration jugee par comparaison des differentes procedures est le sujet principal du chapitre 2. Le resultat essentiel du chapitre 3 est la determination optimale des
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Dahman, Bassam. "NONLINEAR MODELS IN MULTIVARIATE POPULATION BIOEQUIVALENCE TESTING." VCU Scholars Compass, 2009. http://scholarscompass.vcu.edu/etd/1984.

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In this dissertation a methodology is proposed for simultaneously evaluating the population bioequivalence (PBE) of a generic drug to a pre-licensed drug, or the bioequivalence of two formulations of a drug using multiple correlated pharmacokinetic metrics. The univariate criterion that is accepted by the food and drug administration (FDA) for testing population bioequivalence is generalized. Very few approaches for testing multivariate extensions of PBE have appeared in the literature. One method uses the trace of the covariance matrix as a measure of total variability, and another uses a po
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Patterson, Scott Daniel. "Statistical aspects of bioequivalence assessment in the pharmaceutical industry." Thesis, University College London (University of London), 2003. http://discovery.ucl.ac.uk/1383493/.

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Since the early 1990's, average bioequivalence studies have served as the international standard for demonstrating that two formulations of drug product will provide the same therapeutic benefit and safety profile when used in the marketplace. Population (PBE) and Individual (IBE) bioequivalence have been the subject of intense international debate since methods for their assessment were proposed in the late 1980's. Guidance has been proposed by the Food and Drug Administration of the United States government for the implementation of these techniques in the pioneer and generic pharmaceutical
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Khin, Myo Oo Korbtham Sathirakul. "Bioequivalence study of pioglitazone tablets in Thai healthy volunteers /." Abstract, 2007. http://mulinet3.li.mahidol.ac.th/thesis/2550/cd401/4837398.pdf.

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Molins, Lleonart Eduard. "Proposing some innovative study design features to regulatory agencies (EMA and FDA) in bioequivalence trials : Reference Scaled Average Bioequivalence, and Two-Stage Adaptive Designs." Doctoral thesis, Universitat Politècnica de Catalunya, 2021. http://hdl.handle.net/10803/672170.

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In applications for generic medicinal products the concept of bioequivalence is fundamental. Two medicinal products, i.e. a test and a reference drugs containing the same active substance are considered bioequivalent if their bioavailability (rate and extent of absorption of an active substance that is absorbed from a drug product and becomes available at the site of action) after the administration of both products produce a similar therapeutic effect. The assessment of bioequivalence is based upon 90% confidence intervals for the ratio of the population geometric means (test/reference) for t
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Demana, Patrick Hulisani. "Tropical corticosteroid bioequivalence testing comparison of chromameter and visual data." Thesis, Rhodes University, 1998. http://hdl.handle.net/10962/d1003233.

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The major criticism of the human skin blanching assay is the subjective nature of grading the response. Recently the American FDA released a Guidance document for topical corticosteroid bioequi valence testing. The guidelines require the use of a chromameter as a reliable method to estimate skin blanching. The purpose of this study was to evaluate the recommendations of this document for appropriateness by comparing visual and chromameter data. The visually-assessed blanching assay methodology routinely practised in our laboratories was modified to comply with the specifications of the Guidanc
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Zha, Jiuhong. "Metrics evaluating bioavailability and bioequivalence, principles, and applications in the steady state." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1999. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape9/PQDD_0004/NQ41354.pdf.

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Books on the topic "Bioequivalence"

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G, Welling Peter, Tse Francis L. S, and Dighe Shrikant V, eds. Pharmaceutical bioequivalence. Dekker, 1991.

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Yu, Lawrence X., and Bing V. Li, eds. FDA Bioequivalence Standards. Springer New York, 2014. http://dx.doi.org/10.1007/978-1-4939-1252-0.

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Yu, L. X., and Bing V. Li. FDA bioequivalence standards. AAPS Press/Springer, 2014.

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J, Jackson André, ed. Generics and bioequivalence. CRC, 1994.

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International Conference of F.I.P. "Bio-International '96" (1996 Tokyo, Japan). Bioavailability, bioequivalence and pharmacokinetics studies. Japan Scientific Societies Press, 1996.

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Shah, Vinod P., and Howard I. Maibach, eds. Topical Drug Bioavailability, Bioequivalence, and Penetration. Springer US, 1993. http://dx.doi.org/10.1007/978-1-4899-1262-6.

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Shah, Vinod P., Howard I. Maibach, and John Jenner, eds. Topical Drug Bioavailability, Bioequivalence, and Penetration. Springer New York, 2014. http://dx.doi.org/10.1007/978-1-4939-1289-6.

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Kanfer, Isadore, ed. Bioequivalence Requirements in Various Global Jurisdictions. Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-68078-1.

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P, Shah Vinod, and Maibach Howard I, eds. Topical drug bioavailability, bioequivalence, and penetration. Plenum Press, 1993.

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Bio-International '92 (2nd 1992 Bad Homburg, Germany). Bio-international: Bioavailability, bioequivalence and pharmacokinetics. Medpharm, 1993.

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Book chapters on the topic "Bioequivalence"

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Nahler, Gerhard. "Bioequivalence." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_120.

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Blume, Henning H. "Bioequivalence." In Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-56637-5_17-1.

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Blume, Henning H. "Bioequivalence." In Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-319-68864-0_17.

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Lockwood, Graham, and Robert Kringle. "Bioequivalence." In Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer Berlin Heidelberg, 2011. http://dx.doi.org/10.1007/978-3-540-89891-7_17.

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Sasso Aguirre, Jaime. "Bioequivalence." In The ADME Encyclopedia. Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-84860-6_130.

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Sasso Aguirre, Jaime. "Bioequivalence." In The ADME Encyclopedia. Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-51519-5_130-1.

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Hedaya, Mohsen A. "Bioequivalence." In Basic Pharmacokinetics, 3rd ed. Routledge, 2023. http://dx.doi.org/10.4324/9781003161523-8.

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Martinez, Marilyn. "Bioequivalence Studies." In Comparative Pharmacokinetics. Wiley-Blackwell, 2011. http://dx.doi.org/10.1002/9780470959916.ch15.

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Yu, Alex, Duxin Sun, Bing V. Li, and Lawrence X. Yu. "Bioequivalence History." In FDA Bioequivalence Standards. Springer New York, 2014. http://dx.doi.org/10.1007/978-1-4939-1252-0_1.

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Schoenwald, Ronald D. "Bioavailability/Bioequivalence." In Pharmacokinetic Principles of Dosing Adjustments. Routledge, 2023. http://dx.doi.org/10.4324/9780429271373-10.

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Conference papers on the topic "Bioequivalence"

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Belov, Aleksandr, and Kseniya Fimina. "Bioequivalence System for Drug Analysis." In 2022 Interdisciplinary Research in Technology and Management (IRTM). IEEE, 2022. http://dx.doi.org/10.1109/irtm54583.2022.9791517.

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Tie Wang, Jianyang Lin, and Zhiguang Chen. "The bioequivalence identification based on the situ data." In 2008 Chinese Control and Decision Conference (CCDC). IEEE, 2008. http://dx.doi.org/10.1109/ccdc.2008.4598145.

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Teodoro, M. Filomena, Marina A. P. Andrade, and Teresa A. Oliveira. "Evaluating the Bioequivalence of Treatments Using t-ratios Tests." In ICoMS 2024: 2024 7th International Conference on Mathematics and Statistics. ACM, 2024. https://doi.org/10.1145/3686592.3686610.

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Zhou, Chunxiao, and Yongmei Michelle Wang. "An Efficient Permutation Approach for Classical and Bioequivalence Hypothesis Testing of Biomedical Shape Study." In 2008 International Conference on Biomedical Engineering And Informatics (BMEI). IEEE, 2008. http://dx.doi.org/10.1109/bmei.2008.192.

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Athanassiou, Katerina, Luigi Silvestro, and Simona Rizea Savu. "Pharmacokinetic studies for the estimation of bioequivalence of two DPIs containing budesonide and formoterol." In Annual Congress 2015. European Respiratory Society, 2015. http://dx.doi.org/10.1183/13993003.congress-2015.pa2967.

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Winnie, Yeung, Kletzl Heidemarie, Heinig Katja, et al. "Bioequivalence and food effect assessment for a new risdiplam tablet formulation in healthy volunteers." In ABN 2024 annual meeting abstracts. BMJ Publishing Group Ltd, 2024. http://dx.doi.org/10.1136/jnnp-2024-abn.166.

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Allan, R., E. M. Kerwin, M. V. White, et al. "Pulmonary Therapeutic Bioequivalence of Wixela® Inhub® and Advair® Diskus® in Adults with Asthma." In American Thoracic Society 2019 International Conference, May 17-22, 2019 - Dallas, TX. American Thoracic Society, 2019. http://dx.doi.org/10.1164/ajrccm-conference.2019.199.1_meetingabstracts.a2205.

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Iliopoulos, Fotis, Isaac J. Pence, Priyanka Ghosh, Sam G. Raney, Markham C. Luke, and Conor L. Evans. "Stimulated Raman scattering (SRS) microscopy and deep learning: a novel pharmacokinetic approach for evaluation of topical bioequivalence." In Visualizing and Quantifying Drug Distribution in Tissue VII, edited by Conor L. Evans and Kin Foong Chan. SPIE, 2023. http://dx.doi.org/10.1117/12.2649179.

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Sarantopoulos, John, Sanjay Goel, Vincent Chung, et al. "Abstract 4640: Randomized, phase 1 crossover study assessing the bioequivalence of tablet and capsule formulations of dovitinib (TKI258)." In Proceedings: AACR Annual Meeting 2014; April 5-9, 2014; San Diego, CA. American Association for Cancer Research, 2014. http://dx.doi.org/10.1158/1538-7445.am2014-4640.

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"Bayesian modeling of pharmaceutical data addressing the average effect of bivariate parameters of interest in a bioequivalence framework." In 19th International Congress on Modelling and Simulation. Modelling and Simulation Society of Australia and New Zealand (MSSANZ), Inc., 2011. http://dx.doi.org/10.36334/modsim.2011.a1.bartolucci.

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Reports on the topic "Bioequivalence"

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Hwang, Jing-Shiang. Numerical Solutions for Bayes Sequential Decision Approach to Bioequivalence Problem. Defense Technical Information Center, 1991. http://dx.doi.org/10.21236/ada236707.

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Bather, John, and Herman Chernoff. Bounds and Asymptotic Expansions for Solutions of the Free Boundary Problems Related to Sequential Decision Versions of a Bioequivalence Problem. Defense Technical Information Center, 1993. http://dx.doi.org/10.21236/ada273551.

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