{"id":8567,"date":"2020-04-13T11:45:51","date_gmt":"2020-04-13T11:45:51","guid":{"rendered":"http:\/\/box5506.temp.domains\/~direxaco\/?page_id=8567"},"modified":"2020-05-08T13:46:27","modified_gmt":"2020-05-08T13:46:27","slug":"publications","status":"publish","type":"page","link":"https:\/\/direxaconsulting.com\/?page_id=8567","title":{"rendered":"PUBLICATIONS"},"content":{"rendered":"

[et_pb_section fb_built=”1″ admin_label=”Blog Landing Page Header” _builder_version=”4.4.5″ background_color=”#171584″ use_background_color_gradient=”on” background_color_gradient_start=”rgba(0,0,0,0.6)” background_color_gradient_end=”rgba(0,0,0,0.6)” background_color_gradient_direction=”90deg” background_color_gradient_overlays_image=”on” background_image=”https:\/\/direxaconsulting.com\/wp-content\/uploads\/2020\/04\/3d-rendering-viruses-in-infected-organism-viral-disease-epidemic-virus-abstract-background.jpg” custom_padding=”0px||0px||true|false” filter_saturate=”200%” filter_brightness=”133%” background__hover_enabled=”on|desktop”][et_pb_row _builder_version=”4.0.5″ custom_padding=”75px||75px||true|false” animation_style=”slide” animation_direction=”bottom” animation_duration=”2000ms” animation_intensity_slide=”8%”][et_pb_column type=”4_4″ _builder_version=”4.0.5″ animation_direction=”left”][et_pb_text admin_label=”Header Text” _builder_version=”4.4.2″ text_font=”Open Sans||||||||” text_text_color=”#000000″ header_font=”Prata|700|||||||” header_text_align=”center” header_text_color=”#FFFFFF” header_2_font=”Prata||||||||” header_2_text_color=”#ffffff” header_2_font_size=”54px” custom_padding=”24px||||false|false” border_color_top=” #a38b49″]<\/p>\n

Publications<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.4.4″ background_color=”#f7e0a5″][et_pb_row column_structure=”3_4,1_4″ custom_padding_last_edited=”on|desktop” _builder_version=”4.4.3″ background_color=”rgba(0,0,0,0)” custom_padding_tablet=”” custom_padding_phone=””][et_pb_column type=”3_4″ _builder_version=”4.4.3″ background_color=”rgba(0,0,0,0)” custom_padding=”0px|0px|0px|0px|true|true” custom_padding_tablet=”” custom_padding_phone=”|25px||25px|true|true” custom_padding_last_edited=”on|phone” border_width_all=”1px” border_color_all=”#e2e2e2″][et_pb_text admin_label=”Analytic Excellence” _builder_version=”4.4.4″ header_3_font=”Prata||||||||”]<\/p>\n

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The Goldilocks Challenge: Balancing Risk When Setting Product Specifications<\/span><\/h5>\n

by\u00a0Richard K. Burdick & Julia O’Neill\u00a0|\u00a0Jan\/Feb 2020 |<\/span>\u00a0Published in PDA Journal of Pharmaceutical Science and Technology<\/span><\/a><\/span><\/strong><\/p>\n

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Product specifications are ideally based on knowledge of patient needs or requirements of subsequent manufacturing steps. However in most applications, knowledge of patient needs is neither precise nor comprehensive enough to fully define specifications. The prevailing practice is to base specifications on process experience, setting limits to assure consistency of future results with initial results representative of clinical material. Developers of new medicines are often required to set initial product specifications and other limits when only small amounts of process experience have been accumulated. Product developers and health authority reviewers share the mandate to protect patients from harm and assure the effectiveness of medical products, which motivates a tendency to set limits very tight. But although tighter limits give the impression of tighter control, limits alone accomplish no reduction in the variation that exists in established processes and test methods. Limits that are too tight do not represent the natural variability of the process and test methods. Unnaturally tight limits will result in a high number of excursions beyond the limits, potentially causing discards, supply disruptions, and higher cost of goods sold. In this article, we demonstrate how to deliberately control the probability of having intervals that are too tight during the early manufacturing process.<\/span><\/p>\n

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READ MORE<\/strong><\/p>\n

[\/et_pb_text][et_pb_divider color=”#000000″ divider_weight=”2px” _builder_version=”4.4.3″ custom_margin=”||12px||false|false”][\/et_pb_divider][et_pb_text admin_label=”Overcoming Challenges” _builder_version=”4.4.4″ header_3_font=”Prata||||||||” header_5_font=”Prata||||||||” header_5_text_color=”#000000″]<\/p>\n

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Overcoming The Challenges Of Patient-Centric Specification Setting<\/h5>\n

by Julia O’Neill and Richard Burdick | Apr 1, 2020 |<\/span>\u00a0Published in Life Science Leader<\/a><\/span><\/strong><\/p>\n

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If you have ever had a family member diagnosed with a disease such as cancer or a degenerative muscle or cognitive disorder, you likely have encountered barriers to accessing treatments \u2014 high cost, limited supply, delayed commercial launch, or restrictions on clinical trial enrollment. Time is the enemy. Delays in accessing treatment can result in life-altering disease progression or even death.<\/span><\/p>\n

Many factors contribute to the delay in accessing treatment, but one factor is within our power to change \u2014 the way we set specifications for pharmaceuticals.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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READ MORE<\/strong><\/p>\n

[\/et_pb_text][et_pb_divider color=”#000000″ divider_weight=”2px” _builder_version=”4.4.3″ custom_margin=”||12px||false|false”][\/et_pb_divider][et_pb_text admin_label=”Losing Sight” _builder_version=”4.4.4″ header_3_font=”Prata||||||||” header_5_font=”Prata||||||||” header_5_text_color=”#000000″ link_option_url=”https:\/\/www.lifescienceleader.com\/doc\/losing-sight-of-the-intended-purpose-of-specifications-has-consequences-for-the-cmo-sponsor-relationship-0001″]<\/p>\n

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Losing Sight Of The Intended Purpose Of Specifications Has Consequences For The CMO-Sponsor Relationship<\/h5>\n<\/div>\n

by Julia O’Neill\u00a0 | March 7, 2018 |<\/span>\u00a0Published in Life Science Leader<\/a><\/span><\/strong><\/p>\n

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If you\u2019re reading this article, you probably spend most of your working hours focused on creating a reliable supply of medicines at a reasonable cost. But most of us also have been customers for the products we manufacture. When we reach for a bottle of tablets or brace ourselves for an injection at the doctor\u2019s office, we depend on that medicine being safe and effective in treating or preventing disease.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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READ MORE<\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.0.5″][et_pb_text admin_label=”List of Publications” _builder_version=”4.4.5″ text_font=”Prata|700|||||||” text_text_color=”#ffffff” background_color=”#0b1f8f” custom_padding=”24px||24px||false|false” animation_style=”zoom” hover_enabled=”0″ box_shadow_style=”preset2″ background__hover_enabled=”on|hover” background_color__hover=”#a38b49″ background_enable_color__hover=”on”]<\/p>\n

For a more complete <\/span><\/a><\/h4>\n

list of publications,<\/span><\/a><\/h4>\n

click here.<\/span><\/a><\/h4>\n

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Publications The Goldilocks Challenge: Balancing Risk When Setting Product Specifications by\u00a0Richard K. Burdick & Julia O’Neill\u00a0|\u00a0Jan\/Feb 2020 |\u00a0Published in PDA Journal of Pharmaceutical Science and Technology \u00a0 Product specifications are ideally based on knowledge of patient needs or requirements of subsequent manufacturing steps. However in most applications, knowledge of patient needs is neither precise nor […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"footnotes":""},"class_list":["post-8567","page","type-page","status-publish","hentry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t