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searching for Bioequivalence 71 found (100 total)

OMICS Publishing Group (3,645 words) [view diff] no match in snippet view article find links to article

OMICS Publishing Group is a predatory publisher of open access academic journals. It started publishing its first journal in 2008. By 2015, it claimed

Drug Price Competition and Patent Term Restoration Act (1,485 words) [view diff] exact match in snippet view article find links to article

drug acts the same in a human as the innovator drug; this is called bioequivalence. This part of the Act is one of few pieces of legislation that restricts

Equivalence test (1,353 words) [view diff] exact match in snippet view article find links to article

were originally used in areas such as pharmaceutics, frequently in bioequivalence trials. However, these tests can be applied to any instance where the

Gilberto de Nucci (425 words) [view diff] exact match in snippet view article find links to article

throughout bioequivalence essays. He also established the Galeno Research Centre, which conducts clinical trials as well as bioequivalence essays. Both

Boromycin (1,570 words) [view diff] exact match in snippet view article find links to article

Beuerle G, Jiang W, Koenig J, et al. (November 2023). "The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the fifth international EUFEPS/AAPS

Saidal (327 words) [view diff] exact match in snippet view article find links to article

attached. In March 2022, the group announced the launch of its first bioequivalence center called "Equival". Saïdal is headed by : Ali Aoun (1995–2008)

Bupropion (13,383 words) [view diff] exact match in snippet view article find links to article

therapeutic equivalence to Wellbutrin XL 300 mg." The FDA did not test the bioequivalence of any of the other generic versions of Wellbutrin XL 300 mg, but requested

Hydroxybupropion (1,882 words) [view diff] exact match in snippet view article find links to article

Neiner A, Kraus K, Blood J, Stevens A, Schweiger J, et al. (May 2019). "Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults

Pyrimethamine (3,121 words) [view diff] exact match in snippet view article find links to article

prevent generic competitors from legally obtaining the drugs for the bioequivalence studies required for FDA approval of a generic drug. Shkreli defended

Triamterene (1,606 words) [view diff] exact match in snippet view article find links to article

out that Par and Vitarine had each used Mylan's Maxzide to obtain its bioequivalence data, leading both companies to withdraw its generic competitor to Mylan's

Transdermal (1,058 words) [view diff] exact match in snippet view article find links to article

Alam;Correcting endogenous concentrations of testosterone influences bioequivalence and shows the superiority of TDS®-testosterone to Androgel® Int J Clin

Propacetamol (292 words) [view diff] exact match in snippet view article find links to article

Flouvat B, Leneveu A, Fitoussi S, Delhotal-Landes B, Gendron A (2004). "Bioequivalence study comparing a new paracetamol solution for injection and propacetamol

Oxaprozin (883 words) [view diff] exact match in snippet view article find links to article

Daypro by Searle is listed as the Reference Listed Drug to prove the bioequivalence of the ANDAs. Below is a table listing all of the approved oxaprozin

Benzhydrocodone (1,175 words) [view diff] exact match in snippet view article find links to article

amenorrhea or infertility. Hydrocodone use can suppress the immune system. Bioequivalence studies have shown that benzhydrocodone/APAP is bioequivalent to other

University of Veterinary and Animal Sciences (993 words) [view diff] exact match in snippet view article find links to article

Operations Lab (over ISO 17025) Central Laboratory Complex (C.L.C.) Bioequivalence Study Center Pet Center Information Technology center Business Incubation

Seratrodast (1,006 words) [view diff] exact match in snippet view article find links to article

PMID 11829716. S2CID 19276801. An open-labeled, randomized, cross-over bioequivalence study of Seratrodast 80mg under fasting condition. Data on file (appears

Delorazepam (1,953 words) [view diff] exact match in snippet view article find links to article

chromatography-tandem mass spectrometry: application to a cloxazolam bioequivalence study". Biomedical Chromatography. 23 (12): 1266–75. doi:10.1002/bmc

Automatic Generic Substitution (1,096 words) [view diff] exact match in snippet view article find links to article

bioavailability and bioequivalence" (PDF). London: European Medicines Agency. 2000. "Guideline on the investigation of bioequivalence" (PDF). London: European

Valdecoxib (1,520 words) [view diff] exact match in snippet view article find links to article

biological samples like human urine. Valdecoxib has analytical methods for bioequivalence studies, metabolite determination, estimation of formulation, and an

Trimebutine (1,790 words) [view diff] exact match in snippet view article find links to article

Jeon YC, Lee MH, Lee SH, et al. (January 2007). "Pharmacokinetic and bioequivalence evaluation of two formulations of 100 mg trimebutine maleate (Recutin

Levomilnacipran (1,036 words) [view diff] exact match in snippet view article find links to article

D, Chassard D, Baille P, Mignot A, Ung HL, Puozzo C (1998). "Which bioequivalence study for a racemic drug? Application to milnacipran". European Journal

Noncentral t-distribution (2,513 words) [view diff] exact match in snippet view article find links to article

"An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence". The AAPS Journal. 18 (2): 476–489. doi:10.1208/s12248-016-9873-6.

Combination drug (2,485 words) [view diff] exact match in snippet view article find links to article

Yunhui (September 2012). "Challenges and Opportunities in Achieving Bioequivalence for Fixed-Dose Combination Products". The AAPS Journal. 14 (3): 646–655

Astellas Pharma (2,530 words) [view diff] exact match in snippet view article find links to article

Archive. Manufacturers have, in the past, talked up the importance of bioequivalence to encourage prescribing of their brand.... Astellas is now conveniently

Chiral analysis (6,796 words) [view diff] exact match in snippet view article find links to article

production, assess dosage forms, enantiospecific bioavailability and bioequivalence investigations of chiral drugs. Besides pharmaceutical applications

Coefficient of variation (4,017 words) [view diff] exact match in snippet view article find links to article

Hauschke, D; Steinijans, VW (1992). "Sample size determination for bioequivalence assessment by means of confidence intervals". International Journal

Omeprazole (3,865 words) [view diff] exact match in snippet view article find links to article

T, Maia J, Tavares S, Falcão A, et al. (2005). "Bioavailability and bioequivalence of two enteric-coated formulations of omeprazole in fasting and fed

Umifenovir (2,268 words) [view diff] exact match in snippet view article find links to article

Wu HZ, Meng SN, Wei MJ (April 2009). "Pharmacokinetic properties and bioequivalence of two formulations of arbidol: an open-label, single-dose, randomized-sequence

Celgene (2,800 words) [view diff] case mismatch in snippet view article find links to article

THALOMID (thalidomide). Dr. Reddy's Laboratories sought the material for bioequivalency studies required to bring its own, generic, version of thalidomide to

Juniper Publishers (1,128 words) [view diff] exact match in snippet view article find links to article

Surgery Juniper Online Journal of Public Health Modern Applications of Bioequivalence & Bioavailability Novel Approaches in Drug Designing & Development Novel

Esomeprazole (2,777 words) [view diff] exact match in snippet view article find links to article

Vegesna V, Li J, Pollack C, Moreira S (February 2018). "Assessing the bioequivalence of over-the-counter esomeprazole banded capsules and multiple-unit pellet

Chondroitin sulfate (4,168 words) [view diff] exact match in snippet view article find links to article

bioavailability of oral chondroitin sulfate formulations: proposed criteria for bioequivalence studies. Proc. West. Pharmacol. Soc., 2004; 47: 50–53 Adebowale AO Cox

Sarfaraz K. Niazi (978 words) [view diff] exact match in snippet view article find links to article

Biopharmaceutics. Bsp, India. 2010. ISBN 9789381075043. Handbook of Bioequivalence Testing. Boca Raton, Florida: CRC, 2014. ISBN 978-1482226379. Biosimilar

Abacavir (2,750 words) [view diff] exact match in snippet view article find links to article

Prince WT, Stein DS (August 1999). "Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food". Pharmacotherapy. 19

Low-molecular-weight heparin (3,060 words) [view diff] exact match in snippet view article find links to article

Walenga JM, Hoppensteadt D, Fareed J (2013). "Update on the safety and bioequivalence of biosimilars - focus on enoxaparin". Drug, Healthcare and Patient

Certificate of pharmaceutical product (946 words) [view diff] exact match in snippet view article find links to article

product information as per local labelling requirements, and to assess bioequivalence and stability data if necessary. However, regulatory practices often

Sibutramine (3,661 words) [view diff] exact match in snippet view article find links to article

secondary amine metabolites in human plasma and its application to a bioequivalence study". Rapid Communications in Mass Spectrometry. 20 (23): 3509–3521

Sumatriptan (2,875 words) [view diff] exact match in snippet view article find links to article

et al. (2009). "Needle-free subcutaneous sumatriptan (Sumavel DosePro): bioequivalence and ease of use". Headache. 49 (10): 1435–1444. doi:10.1111/j.1526-4610

International Center for Chemical and Biological Sciences (1,248 words) [view diff] exact match in snippet view article find links to article

Drug Research Third World Center for Science and Technology Center for Bioequivalence Studies and Clinical Research (CBSCR) Industrial Analytical Center (IAC)

Ciclosporin (5,403 words) [view diff] exact match in snippet view article find links to article

January 2014. Ehinger KH, Hansson MJ, Sjövall F, Elmér E (January 2013). "Bioequivalence and tolerability assessment of a novel intravenous ciclosporin lipid

Frédéric Y. Bois (1,073 words) [view diff] exact match in snippet view article find links to article

Safety and Health Administration. He contributed mostly to the fields of bioequivalence testing, health risk assessment, population pharmacokinetics and Bayesian

Sheikh Zayed Foundation (480 words) [view diff] exact match in snippet view article find links to article

institutes of higher education, three research centers, one center of bioequivalence studies, and several mobile care units. The Sheikh Zayed foundation

JSciMed Central (1,097 words) [view diff] exact match in snippet view article find links to article

Depression JSM Arthritis JSM Atherosclerosis JSM Bioavailability and Bioequivalence JSM Biochemistry and Molecular Biology JSM Bioinformatics, Genomics

Food and Drug Administration (12,213 words) [view diff] exact match in snippet view article find links to article

administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This Act has been credited with

Amoxapine (2,742 words) [view diff] exact match in snippet view article find links to article

Rawson MJ, Hsia D (September 1999). "The role of metabolites in a bioequivalence study II: amoxapine, 7-hydroxyamoxapine, and 8-hydroxyamoxapine". International

Dissolution testing (1,675 words) [view diff] exact match in snippet view article find links to article

Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop". CPT: Pharmacometrics

Dexmethylphenidate (3,873 words) [view diff] exact match in snippet view article find links to article

Stypinski D, et al. (February 2004). "A single-dose, two-way crossover, bioequivalence study of dexmethylphenidate HCl with and without food in healthy subjects"

Ofloxacin (4,422 words) [view diff] exact match in snippet view article find links to article

original on 26 August 2016. Flor SC, Rogge MC, Chow AT (July 1993). "Bioequivalence of oral and intravenous ofloxacin after multiple-dose administration

Mylan (6,418 words) [view diff] exact match in snippet view article find links to article

initial investigation and were found to have used Maxzide to obtain their bioequivalence data, leading both companies to withdraw its generic competitor to Mylan's

Clinical trial (12,989 words) [view diff] exact match in snippet view article find links to article

Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans". fda.gov. Center for Drug Evaluation and Research

Tramadol (9,252 words) [view diff] exact match in snippet view article find links to article

and its O-desmethylated metabolite in blood plasma. Application to a bioequivalence study in humans". Journal of Chromatography A. 949 (1–2): 11–22. doi:10

Howard Maibach (1,592 words) [view diff] exact match in snippet view article find links to article

Howard Maibach (Editor), published 2017. Topical Drug Bioavailability, Bioequivalence, and Penetration, Second Edition, by Vinod P. Sha (Editor), Howard Maibach

TNO intestinal model (647 words) [view diff] exact match in snippet view article find links to article

Gastrointestinal tract to support formulation development and establish bioequivalence of poorly soluble drugs." AAPS Journal, 14 (2): p196-205. Havenaar,

Chinedum Babalola (1,897 words) [view diff] exact match in snippet view article find links to article

Chemotherapy 53(6):1098-1100. Babalola CP; et al. (2004) Bioavailability and bioequivalence (BA/BE) assessment. Towards Better Quality Assurance of Drugs in the

History of the Food and Drug Administration (3,469 words) [view diff] exact match in snippet view article find links to article

administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This act has been credited with

Conjugated estrogens (6,516 words) [view diff] exact match in snippet view article find links to article

doi:10.1210/edrv-9-4-396. PMID 3065072. Ansbacher R (April 1993). "Bioequivalence of conjugated estrogen products". Clinical Pharmacokinetics. 24 (4):

Meir Bialer (929 words) [view diff] exact match in snippet view article find links to article

(2020). R. Odi, V. Franco, E. Perucca, M. Bialer. A perspective on bioequivalence and switchability of generic AED products. Epilepsia 62: 285-302 (2021)

Biomedical research in the United States (2,404 words) [view diff] exact match in snippet view article find links to article

be approved on the basis of minimal and inexpensive tests to prove bioequivalence. Since biological drugs are complex, heterogeneous products derived

Aspen Pharmacare (3,612 words) [view diff] exact match in snippet view article find links to article

recommendations such as reevaluating methods used to determine "the bioequivalence of levothyroxine preparations". Since 2018 the company admits a "commercial

Pharmacokinetics of estradiol (26,910 words) [view diff] exact match in snippet view article find links to article

tb04000.x. PMID 9751449. S2CID 23550553. Timmer CJ, Geurts TB (1999). "Bioequivalence assessment of three different estradiol formulations in postmenopausal

Estradiol valerate (9,447 words) [view diff] exact match in snippet view article find links to article

tb04000.x. PMID 9751449. S2CID 23550553. Timmer CJ, Geurts TB (1999). "Bioequivalence assessment of three different estradiol formulations in postmenopausal

Non-biological complex drugs (1,457 words) [view diff] exact match in snippet view article find links to article

classical generic paradigm based on pharmaceutical equivalence and bioequivalence without realizing the nano-properties of these type of medicinal compounds

Ethinylestradiol/drospirenone/prasterone (467 words) [view diff] exact match in snippet view article find links to article

AdisInsight". Zimmerman Y, Wouters W, Coelingh Bennink HJ (June 2013). "The bioequivalence of the contraceptive steroids ethinylestradiol and drospirenone is not

7-Hydroxyamoxapine (176 words) [view diff] exact match in snippet view article find links to article

Rawson MJ, Hsia D (September 1999). "The role of metabolites in a bioequivalence study II: amoxapine, 7-hydroxyamoxapine, and 8-hydroxyamoxapine". International

Frederick D Sancilio (1,432 words) [view diff] exact match in snippet view article find links to article

Daak, Ahmed; Rabinowicz, Adrian L.; Sancilio, Frederick D. (2017). "Bioequivalence Demonstration for Ω-3 Acid Ethyl Ester Formulations: Rationale for Modification

Autophagic vacuolar myopathy (2,589 words) [view diff] exact match in snippet view article find links to article

Retrieved 2020-03-29. Ratner M (Aug 2009). "Genzyme's Lumizyme clears bioequivalence hurdles". Nature Biotechnology. 27 (8): 685. doi:10.1038/nbt0809-685a

January 1965 (13,946 words) [view diff] exact match in snippet view article find links to article

Casemate Publishers. p. 40. Niazi, Sarfaraz K. (2014). Handbook of Bioequivalence Testing. CRC Press. p. 423. Morell, Virginia (2011). Ancestral Passions:

List of investigational antidepressants (11,427 words) [view diff] exact match in snippet view article find links to article

pdf#page=12 Lipocine Inc. (25 June 2024). "Lipocine Announces LPCN 1154 Meets Bioequivalence with IV Brexanolone in Pivotal Study". PR Newswire. Retrieved 9 August

8-Hydroxyamoxapine (164 words) [view diff] exact match in snippet view article find links to article

Rawson MJ, Hsia D (September 1999). "The role of metabolites in a bioequivalence study II: amoxapine, 7-hydroxyamoxapine, and 8-hydroxyamoxapine". International

List of Guidances for Statistics in Regulatory Affairs (3,027 words) [view diff] exact match in snippet view article find links to article

IND and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. FDA: Adverse

(2R,3R)-Hydroxybupropion (1,733 words) [view diff] exact match in snippet view article

Lenze EJ (November 2020). "Stereoselective Steady-State Disposition and Bioequivalence of Brand and Generic Bupropion in Adults". Clin Pharmacol Ther. 108