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Bioequivalentes

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Preview of 76 FR 38668 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting
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76 FR 38668 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting (2011-16576.pdf)

143 KBEN 2 pages
The FDA announces a meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on July 26, 2011, to discuss bioequivalence issues...
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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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Generic Medicines: Definition, Contents, and Development Timeline (questions-answers-generic-medicines_et.pdf)

66 KBEuropean Medicines AgencyEN 3 pages
A generic medicine is an identical copy of an existing authorized medication, with the same active substance, dose, and treatment purpose, but potentially different branding and packaging. It requires approval to demonstrate bioequivalence to the reference medicine.
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Preview of Greek
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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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