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Bioequivalentes Reference

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6 documents available in our comprehensive collection of Bioequivalentes Reference resources. Find practical guides, tutorials, and documentation to enhance your knowledge.

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Generic Medicines: Definition, Contents, and Development Timeline (questions-answers-generic-medicines_et.pdf)

66 KBEuropean Medicines AgencyEN 3 pages
It requires approval to demonstrate bioequivalence to the reference medicine
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Preview of Bioequivalence Studies of Two Formulations of Rivaroxaban 10 Mg Coated Tablets under Fasting Conditions and 20 Mg Coated Tablets
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Bioequivalence Studies of Two Formulations of Rivaroxaban 10 Mg Coated Tablets under Fasting Conditions and 20 Mg Coated Tablets (9103-Bioequivalence-Studies.pdf)

385 KBEN 14 pages
A bioequivalence study was conducted to compare two formulations of rivaroxaban (10mg and 20mg coated tablets) manufactured by Eurofarma Laboratórios S/A with...
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Greek (gvk-biosciences-article-31-referral-annex-iii_el.pdf)

40 KBEN 2 pages
The National Competent Authorities must ensure the Marketing Authorisation Holder (MAH) fulfils the condition that suspension of marketing authorisations is...
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Latvian (gvk-biosciences-article-31-referral-annex-ii_lv.pdf)

84 KBEN 12 pages
The French Agency on medicinal products (ANSM) inspected GVK Biosciences Private Limited in India from 19-23 May 2014 and found data manipulations of...
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Download PDF (inh_20150401_0014.pdf)

874 KBBenjamin WeberEN 7 pages
Objective methods for evaluating the equivalence of aerodynamic particle size distributions (APSD) are crucial for determining whether a generic inhalable drug...
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Lacosamide Accord, INN - lacosamide (lacosamide-accord-epar-summary-public_hr.pdf)

92 KBCHMPEN 3 pages
Document en en
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