{"id":436,"date":"2025-11-29T01:38:37","date_gmt":"2025-11-28T18:38:37","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/11\/29\/rangkuman-berita-mingguan-pharmtech-minggu-tanggal-24-november-2025\/"},"modified":"2025-11-29T01:38:37","modified_gmt":"2025-11-28T18:38:37","slug":"rangkuman-berita-mingguan-pharmtech-minggu-tanggal-24-november-2025","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/11\/29\/rangkuman-berita-mingguan-pharmtech-minggu-tanggal-24-november-2025\/","title":{"rendered":"Rangkuman Berita Mingguan PharmTech \u2014 Minggu tanggal 24 November 2025"},"content":{"rendered":"<div id=\"block-content\">\n<p class=\"\">Dalam fitur video PharmTech ini, kami menyoroti berita industri minggu ini dalam format yang mudah dikonsumsi dan menyenangkan. Kumpulan baru akan dirilis setiap hari Jumat, jadi pastikan untuk kembali setiap minggunya.<\/p>\n<p class=\"\">Secara kolektif, liputan minggu ini membahas perkembangan terkini industri farmasi dan lanskap peraturan saat ini. Baca terus untuk rekap setiap cerita yang telah kami bahas.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Aplikasi utama AI dalam pengembangan obat?<\/strong><\/h2>\n<p class=\"\">Kecerdasan buatan (AI) dan alat pembelajaran mesin <astro-island uid=\"ZoP0XW\" prefix=\"r46\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;63e5d1293061&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;are now driving transformative shifts&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;458335a43b11&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/faq-key-ai-applications-in-drug-development&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;458335a43b11&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">kini mendorong perubahan transformatif<!--astro:end--><\/astro-island>    melintasi bioanalisis, pengujian praklinis, dan optimalisasi formulasi di seluruh industri. Dalam penemuan obat, model tingkat lanjut memprediksi teknologi pelarutan optimal untuk kandidat yang sukar larut dan mengkarakterisasi interaksi obat-eksipien, yang secara sistematis mengurangi ketergantungan pada uji coba empiris dan meminimalkan konsumsi API. Kembar digital, yang dilatih menggunakan data multi-modal berskala besar, juga meningkatkan evaluasi praklinis dengan memperkirakan fungsi organ secara akurat dan memungkinkan analisis statistik berpasangan, yang dapat mempercepat penemuan obat dengan mengurangi ukuran penelitian.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Apa implikasi regulasi\/risiko dari jadwal peninjauan yang padat?<\/strong><\/h2>\n<p class=\"\">Program percontohan Voucher Prioritas Nasional (CNPV) Komisaris FDA <astro-island uid=\"2p6wa9\" prefix=\"r47\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;a2b3d3ad842e&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;offers the unprecedented opportunity&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;deaefedb597d&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/industry-expert-panel-weighs-cnpv-benefits-risks-and-readiness-part-i&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;deaefedb597d&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">menawarkan peluang yang belum pernah terjadi sebelumnya<!--astro:end--><\/astro-island>    untuk mengurangi waktu peninjauan penggunaan obat dari 10\u201312 bulan menjadi hanya satu atau dua bulan, khususnya untuk memberikan manfaat pada obat generik dan biosimilar. Percepatan ini mengharuskan sponsor untuk melakukan aktivitas akses pasar, manufaktur, dan kesiapan pasca-persetujuan secara paralel, dimulai sejak awal pengembangan, karena tidak ada waktu untuk memperbaiki kesenjangan kepatuhan setelah file diserahkan. Oleh karena itu, jadwal yang padat memperkuat setiap kelemahan dalam kerangka manajemen risiko kualitas perusahaan, menuntut persiapan inspeksi yang proaktif dan investasi awal dalam bidang kimia, manufaktur, dan kekuatan kontrol.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Dimana manfaat onshoringnya?<\/strong><\/h2>\n<p class=\"\"><astro-island uid=\"1vgR4c\" prefix=\"r48\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;7fe13e6aef8c&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;Onshoring is an explicit selection criterion&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;bf978b3cd41b&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/industry-expert-panel-weighs-cnpv-benefits-risks-and-readiness-part-ii&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;bf978b3cd41b&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Onshoring adalah kriteria seleksi yang eksplisit<!--astro:end--><\/astro-island>    untuk program CNPV, yang digunakan FDA untuk mengarahkan manufaktur tingkat lanjut, terutama produk suntik steril dan produk biologis, kembali ke Amerika Serikat untuk memperkuat ketahanan rantai pasokan. Hal ini memberikan banyak peluang bagi sponsor generik dan biosimilar untuk melakukan komunikasi pra-pengajuan yang signifikan dengan FDA\u2014suatu kemewahan yang jarang terjadi bagi sponsor obat generik non-kompleks\u2014dengan harapan bahwa sebagian besar masalah diselesaikan sebelum berkas diajukan secara resmi. Program ini bertujuan untuk menjaga pengetahuan manufaktur yang penting, mendorong modernisasi melalui manufaktur berkelanjutan, dan meningkatkan ketangkasan peraturan dengan memanfaatkan fasilitas berbasis di AS yang lebih mudah untuk diperiksa.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Apa rencana FDA untuk akses epinefrin?<\/strong><\/h2>\n<p class=\"\">FDA, bekerja sama dengan Duke University, adalah <astro-island uid=\"2s9pws\" prefix=\"r49\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;171f9fc375a4&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;convening a public workshop&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;81a72fb5c6d8&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/fda-duke-university-planning-epinephrine-access-workshop-for-december&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;81a72fb5c6d8&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">mengadakan lokakarya umum<!--astro:end--><\/astro-island>    untuk memulai diskusi tentang perluasan aksesibilitas dan penggunaan epinefrin untuk mengurangi morbiditas dan mortalitas terkait anafilaksis. Fokus ini mengikuti persetujuan global baru-baru ini terhadap Neffy, formulasi epinefrin semprot hidung yang dikembangkan oleh ARS Pharmaceuticals, yang menyediakan alternatif tanpa jarum suntik dibandingkan perangkat injektor otomatis tradisional. Inovasi ini mengatasi tantangan klinis dimana pasien, khususnya kaum muda, mungkin enggan membawa atau menggunakan perangkat auto-injector dengan benar karena takut atau stigma.<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Dalam fitur video PharmTech ini, kami menyoroti berita industri minggu ini dalam format yang mudah dikonsumsi dan menyenangkan. Kumpulan baru akan dirilis setiap hari Jumat, jadi pastikan untuk kembali setiap minggunya. Secara kolektif, liputan minggu ini membahas perkembangan terkini industri farmasi dan lanskap peraturan saat ini. Baca terus untuk rekap setiap cerita yang telah kami [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":427,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-436","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Rangkuman Berita Mingguan PharmTech \u2014 Minggu tanggal 24 November 2025 - Nova Anggreni, S.Farm, APT<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pythonsonline.com\/index.php\/2025\/11\/29\/rangkuman-berita-mingguan-pharmtech-minggu-tanggal-24-november-2025\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Rangkuman Berita Mingguan PharmTech \u2014 Minggu tanggal 24 November 2025 - Nova Anggreni, S.Farm, APT\" \/>\n<meta property=\"og:description\" content=\"Dalam fitur video PharmTech ini, kami menyoroti berita industri minggu ini dalam format yang mudah dikonsumsi dan menyenangkan. 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