{"id":80900,"date":"2019-11-15T19:01:45","date_gmt":"2019-11-15T22:01:45","guid":{"rendered":"https:\/\/megalabs.global\/eng\/?page_id=80900"},"modified":"2020-05-29T21:15:45","modified_gmt":"2020-05-30T00:15:45","slug":"safety-and-support","status":"publish","type":"page","link":"https:\/\/megalabs.global\/eng\/safety-and-support\/","title":{"rendered":"Safety and Support"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;100&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;3&#8243; back_color=&#8221;color-877404&#8243; back_image=&#8221;81045&#8243; back_position=&#8221;left bottom&#8221; kburns=&#8221;yes&#8221; overlay_alpha=&#8221;1&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; css=&#8221;.vc_custom_1574092058956{padding-left: 0px !important;}&#8221; el_class=&#8221;slider-contenedor-d11&#8243;][vc_column column_width_percent=&#8221;100&#8243; 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position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; expand_height=&#8221;yes&#8221; style=&#8221;dark&#8221; font_family=&#8221;font-195522&#8243; overlay_color=&#8221;color-877404&#8243; overlay_alpha=&#8221;85&#8243; border_color=&#8221;color-143419&#8243; border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845317851{border-bottom-width: 0px !important;border-left-width: 20px !important;padding-top: 50px !important;padding-right: 50px !important;padding-bottom: 10px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]Developing high quality pharmaceutical products is the challenge driving us.[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; 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border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845549779{border-top-width: 0px !important;border-left-width: 20px !important;padding-top: 10px !important;padding-right: 50px !important;padding-bottom: 70px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading heading_semantic=&#8221;h4&#8243; text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]To achieve this, we must go beyond the pharmaceutical quality of our products and comply with the latest demands for efficacy and safety, through:<\/p>\n<ul>\n<li>Bioequivalence studies<\/li>\n<li>Interchangeability and biosimilarity demonstration for biotech products<\/li>\n<li>Safety and efficacy clinical studies<\/li>\n<li>Pharmacokinetic-pharmacodynamic studies, for complex non-biological products (CNBP)<\/li>\n<li>Pharmacovigilance management<\/li>\n<li>Product documentation and updated information<\/li>\n<\/ul>\n<p>[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; 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Thus, we promote the safe, effective and sensible use of drugs. To do this, we provide updated information on the use, indications and safety of our products.[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573837922719{border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;100&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;3&#8243; back_color=&#8221;color-877404&#8243; back_image=&#8221;80909&#8243; back_position=&#8221;left bottom&#8221; 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This site allows healthcare professionals and patients to document any kind of inconvenience with their use. 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border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845574834{border-top-width: 0px !important;border-left-width: 20px !important;padding-top: 10px !important;padding-right: 50px !important;padding-bottom: 70px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading heading_semantic=&#8221;h4&#8243; text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]We believe it is our obligation to provide physicians and patients with the most up-to-date information on the products they use.<br \/>\nIn order to provide physicians and patients with the most up-to-date information on our products, we have information from high health surveillance agencies, as well as global scientific literature and aggregated reports on pharmacovigilance. In addition, this information complies with the national requirements of the countries where we market our products.[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573837922719{border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;100&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;3&#8243; back_color=&#8221;color-877404&#8243; back_image=&#8221;80905&#8243; back_position=&#8221;left bottom&#8221; 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position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; expand_height=&#8221;yes&#8221; style=&#8221;dark&#8221; font_family=&#8221;font-195522&#8243; overlay_color=&#8221;color-877404&#8243; overlay_alpha=&#8221;85&#8243; border_color=&#8221;color-143419&#8243; border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845317851{border-bottom-width: 0px !important;border-left-width: 20px !important;padding-top: 50px !important;padding-right: 50px !important;padding-bottom: 10px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]Bioequivalence[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573837954391{border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;0&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; el_class=&#8221;sin-margin-top&#8221; limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; expand_height=&#8221;yes&#8221; style=&#8221;dark&#8221; font_family=&#8221;font-195522&#8243; overlay_color=&#8221;color-877404&#8243; overlay_alpha=&#8221;85&#8243; border_color=&#8221;color-774395&#8243; border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845574834{border-top-width: 0px !important;border-left-width: 20px !important;padding-top: 10px !important;padding-right: 50px !important;padding-bottom: 70px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading heading_semantic=&#8221;h4&#8243; text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]Megalabs aims at having medicines, not only of the highest quality, but also to ensure predictable therapeutic results. To do this, we carry out bioequivalence studies, comparing plasma concentrations and pharmacokinetic parameters of our products and those of reference worldwide. Our policy of developing bioequivalence products is one of the pillars of our leadership.[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573837922719{border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;100&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;3&#8243; back_color=&#8221;color-877404&#8243; back_image=&#8221;81386&#8243; back_position=&#8221;left bottom&#8221; 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position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; expand_height=&#8221;yes&#8221; style=&#8221;dark&#8221; font_family=&#8221;font-195522&#8243; overlay_color=&#8221;color-877404&#8243; overlay_alpha=&#8221;85&#8243; border_color=&#8221;color-143419&#8243; border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845317851{border-bottom-width: 0px !important;border-left-width: 20px !important;padding-top: 50px !important;padding-right: 50px !important;padding-bottom: 10px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]Bioequivalence and pharmacovigilance: one objective[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573837954391{border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;0&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; el_class=&#8221;sin-margin-top&#8221; limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; expand_height=&#8221;yes&#8221; style=&#8221;dark&#8221; font_family=&#8221;font-195522&#8243; overlay_color=&#8221;color-877404&#8243; overlay_alpha=&#8221;85&#8243; border_color=&#8221;color-774395&#8243; border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845574834{border-top-width: 0px !important;border-left-width: 20px !important;padding-top: 10px !important;padding-right: 50px !important;padding-bottom: 70px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading heading_semantic=&#8221;h4&#8243; text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]At the intersection between bioequivalence and pharmacovigilance we find the explanation for the therapeutic failure or success of any product.<\/p>\n<p>Our organization carries out an average of 40 annual bioequivalence studies, which comply with the international regulations of Good Clinical Practices, the latest ethical regulations, and the guidelines of the local Health Authorities and high health surveillance agencies.[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; 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shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845559666{border-top-width: 0px !important;border-left-width: 20px !important;padding-top: 10px !important;padding-right: 50px !important;padding-bottom: 70px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading heading_semantic=&#8221;h4&#8243; text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]We carry out pre-clinical studies to determine the pharmacokinetic and pharmacodynamic profile, therapeutic effect and toxicity in animals of our products. These studies demonstrate its safe use in the subsequent clinical studies.[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573837922719{border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;100&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;3&#8243; back_color=&#8221;color-877404&#8243; back_image=&#8221;80890&#8243; back_position=&#8221;left bottom&#8221; kburns=&#8221;yes&#8221; 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position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; expand_height=&#8221;yes&#8221; style=&#8221;dark&#8221; font_family=&#8221;font-195522&#8243; overlay_color=&#8221;color-877404&#8243; overlay_alpha=&#8221;85&#8243; border_color=&#8221;color-143419&#8243; border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845317851{border-bottom-width: 0px !important;border-left-width: 20px !important;padding-top: 50px !important;padding-right: 50px !important;padding-bottom: 10px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]Clinical studies[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573837954391{border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;0&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; el_class=&#8221;sin-margin-top&#8221; limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; expand_height=&#8221;yes&#8221; style=&#8221;dark&#8221; font_family=&#8221;font-195522&#8243; overlay_color=&#8221;color-877404&#8243; overlay_alpha=&#8221;85&#8243; border_color=&#8221;color-774395&#8243; border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;right-t-left&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1573845574834{border-top-width: 0px !important;border-left-width: 20px !important;padding-top: 10px !important;padding-right: 50px !important;padding-bottom: 70px !important;padding-left: 50px !important;}&#8221;][vc_custom_heading heading_semantic=&#8221;h4&#8243; text_font=&#8221;font-195522&#8243; text_size=&#8221;&#8221; text_weight=&#8221;300&#8243;]The clinical studies we carry out are intended to determine the safety and\/or efficacy of our products, by verifying clinical effects, pharmacokinetic profile, and possible adverse reactions.<\/p>\n<p>In carrying them out, we ensure that we comply with good practices and the Declaration of Helsinki on ethical principles.[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; 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