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searching for Bioequivalence 62 found (91 total)

alternate case: bioequivalence

OMICS Publishing Group (3,359 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 (1,295 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
Triamterene (1,550 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
Gilberto de Nucci (417 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
Pyrimethamine (3,056 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
Bupropion (8,847 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
Transdermal (1,060 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
Frédéric Y. Bois (2,190 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
Combination drug (904 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
Oxaprozin (845 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
Trimebutine (314 words) [view diff] exact match in snippet view article find links to article
Jeon YC, Lee MH, Lee SH, Kang JS (January 2007). "Pharmacokinetic and bioequivalence evaluation of two formulations of 100 mg trimebutine maleate (Recutin
Biopharmaceutics Classification System (617 words) [view diff] exact match in snippet view article find links to article
of 1 to 7.5. The volume estimate of 250 ml is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting
Seratrodast (1,001 words) [view diff] exact match in snippet view article find links to article
1517/13543784.11.2.275. PMID 11829716. An open-labeled, randomized, cross-over bioequivalence study of Seratrodast 80mg under fasting condition. Data on file (appears
Saidal (236 words) [view diff] exact match in snippet view article find links to article
Pharmal and Antibiotical were attached. January 4, 2016, the national bioequivalence center, the first in Algeria, was inaugurated by the Minister of Industry
Delorazepam (1,883 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
Levomilnacipran (904 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
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
Primeasia University (1,438 words) [view diff] exact match in snippet view article find links to article
Advanced Instrumental Research Laboratory Advanced Biopharmaceutics & Bioequivalence Research Laboratory Advanced Biotechnology Research Laboratory Advanced
International Pharmaceutical Federation (979 words) [view diff] exact match in snippet view article find links to article
groups have been formed on the following areas: Bioavailability and Bioequivalence Biopharmaceutics Classification System Dissolution Environment and pharmaceuticals
Valdecoxib (1,280 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
University of Veterinary and Animal Sciences (964 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
Astellas Pharma (2,153 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
Automatic Generic Substitution (1,092 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
Sibutramine (2,963 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 Comm. Mass Spec. 20: 3509-3521, 2006. Thevis M, Sigmund
Sumatriptan (2,017 words) [view diff] exact match in snippet view article find links to article
S. (2009). "Needle-free subcutaneous sumatriptan (Sumavel DosePro): bioequivalence and ease of use". Headache. 49 (10): 1435–1444. doi:10.1111/j.1526-4610
Certificate of pharmaceutical product (817 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
Coefficient of variation (3,739 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
Chondroitin sulfate (3,947 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
Omeprazole (3,871 words) [view diff] exact match in snippet view article find links to article
Almeida, Luis; Soares-Da-Silva, Patricio (2005). "Bioavailability and Bioequivalence of Two Enteric-Coated Formulations of Omeprazole in Fasting and Fed
Esomeprazole (2,433 words) [view diff] exact match in snippet view article find links to article
Pollack, Charles; Moreira, Sebastian (1 February 2018). "Assessing the bioequivalence of over-the-counter esomeprazole banded capsules and multiple-unit pellet
Celgene (2,599 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
Chiral analysis (6,664 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
Abacavir (2,769 words) [view diff] exact match in snippet view article find links to article
Research Triangle Park, NC, 2015. Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food. G. E. Chittick, C. Gillotin
Low-molecular-weight heparin (3,056 words) [view diff] exact match in snippet view article find links to article
3 (2011) S100–S104 Jeske, Walter (2013). "Update on the safety and bioequivalence of biosimilars – focus on enoxaparin". Drug Healthc. Patient Saf. 5:
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
Coenzyme Q10 (5,293 words) [view diff] exact match in snippet view article find links to article
Kommuru TR, Ashraf M, Khan MA, Reddy IK (July 1999). "Stability and bioequivalence studies of two marketed formulations of coenzyme Q10 in beagle dogs"
Ciclosporin (4,735 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
Food and Drug Administration (11,398 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
Dissolution testing (1,671 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
Meir Bialer (924 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)
Amoxapine (2,550 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
Tramadol (7,741 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
History of the Food and Drug Administration (3,319 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
Dexmethylphenidate (4,674 words) [view diff] exact match in snippet view article find links to article
Stypinski D, Khetani VD (February 2004). "A single-dose, two-way crossover, bioequivalence study of dexmethylphenidate HCl with and without food in healthy subjects"
Mylan (6,299 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
Sheikh Zayed Foundation (478 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
Clinical trial (11,171 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
Ofloxacin (4,481 words) [view diff] exact match in snippet view article find links to article
at the Wayback Machine Flor, SC; Rogge, MC; Chow, AT (July 1993). "Bioequivalence of oral and intravenous ofloxacin after multiple-dose administration
Chinedum Peace Babalola (1,689 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
TNO intestinal model (584 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,
Conjugated estrogens (6,351 words) [view diff] exact match in snippet view article find links to article
1210/edrv-9-4-396. ISSN 0163-769X. PMID 3065072. Ansbacher R (April 1993). "Bioequivalence of conjugated estrogen products". Clin Pharmacokinet. 24 (4): 271–4
Sarfaraz K. Niazi (1,231 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
Estradiol valerate (9,273 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 (1,459 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
Pharmacokinetics of estradiol (26,664 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
Biomedical research in the United States (2,408 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
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
January 1965 (12,491 words) [view diff] exact match in snippet view article find links to article
American History (ABC-CLIO, 2016) p393 Sarfaraz K. Niazi, Handbook of Bioequivalence Testing (CRC Press, 2014) p423 Virginia Morell, Ancestral Passions:
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
List of Guidances for Statistics in Regulatory Affairs (2,823 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
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