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Teko e ncha ea Thahasello ea Thobalano ea Basali / Bothata ba ho Arousal (FSIAD)

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Freya Pharma Solutions kajeno e phatlalalitse hore e sirelelitse US $ 8.5 milione ka lichelete tse ncha ho tsoa ho batseteli ba teng le ba bacha. Chelete e ncha e tla sebelisoa ho etsa teko ea bohlokoa ea mohato oa 3 ka kalafo ea eona ea Lybrido ho bakuli ba 516 ho pholletsa le Europe. Nakong e fetileng, Lybrido o ile a bontša bohlokoa ba kliniki le bohlokoa ba lipalo-palo tekong ea kliniki ea mohato oa 2b, ho finyella ka ho hlaka lintlha tsa mantlha. Teko ea karolo ea 3 e tla qala halofo ea bobeli ea 2022, 'me liphetho tsa nakoana li lebelletsoe halofo ea bobeli ea 2023.

Teko e tlang ea bohlokoa ea mohato oa 3

Freya Pharma Solutions e rera ho etsa teko ea bohlokoa ea kliniki ea mohato oa 3 ho netefatsa katleho ea Lybrido ho basali ba nang le thahasello ea thobalano / bothata ba ho tsosoa ke thobalano (FSIAD). Mokhatlo oa lipatlisiso tsa Clinical CR2O BV (www.CR2O.nl) o etella pele ho lokisoa, ho phethahatsa le ho tlaleha teko ea bongaka ea Mokhahlelo oa 3. CR2O ke mokhatlo o fanang ka litšebeletso tse felletseng tsa likonteraka tsa kliniki o ikemiselitseng ho nts'etsapele liphekolo tse ncha bakeng sa litlhoko tse sa fihlelleheng tsa bongaka.

Lithuto tsa pele tsa bongaka le tsa bongaka, tlhahiso le nts'etsopele ea Lybrido li entsoe ho latela melaoana ea EU GLP, GMP le GCP.

Ho lebelletsoe hore ho tla tšoaroa Seboka sa Keletso ea Mahlale le EMA pele teko ea mohato oa 3 e qala. Sepheo se seholo sa seboka seo e ne e tla ba ho netefatsa ho amoheleha ha mohato oa 3 oa protocol ea moralo oa teko, hammoho le leano la kakaretso la ntlafatso ea bongaka.

Teko ea kliniki ea mohato oa 3 e tla etsoa ka hare ho European Union ho latela Mekhoa e Metle ea Clinical Practices le melaoana ea boitšoaro e boletsoeng Phatlalatsong ea Helsinki. E tla lumellana le EU Clinical Trial Regulation (No. 536/2014), melao le litaelo tse ling tsohle tse sebetsang, hammoho le litlhoko tsa Litho tse amehang moo thuto e etsoang teng.

Marcel Wijma, Motsamaisi e Moholo oa Freya Pharma Solutions o re, "Re thabetse ts'epo le ts'epo ho tsoa ho beng ba rona ba hajoale le ba bacha menyetla ea ho ntšetsa pele kalafo ena ea mantlha ea basali ba nang le FSIAD 'marakeng ka nako. 'Me re ikemiselitse ka botlalo ho tlisa kalafo bakeng sa FSIAD ho palo e kholo ea bakuli lefatšeng ka bophara ba nang le bothata bona bo sithabetsang. ”

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mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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