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Latest twenty posts

• 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ [Design Issues]: Helmut 1 day 06:27 ago
• RLD strength for BE study [Design Issues]: Brus 1 day 06:40 ago
• In memoriam László Endrényi 🥀 [Off Topic]: Leni 2 days 08:53 ago
• Terminology: Fed study [Regulatives / Guidelines]: Pharma_88 2 days 09:49 ago
• FDA: ANDA during COVID-19 pandemic [BE/BA News]: Helmut 3 days 03:37 ago
• Single site? [General Sta­tis­tics]: Helmut 3 days 09:32 ago
• Group Effect [General Sta­tis­tics]: alghazam 3 days 22:32 ago
• Related stuff [Software]: Helmut 8 days 08:11 ago
• Intra Subject Variability [General Sta­tis­tics]: jag009 16 days 20:53 ago
• 0.001 > 0 [RSABE / ABEL]: yogeshla 17 days 08:31 ago
• 0.001 > 0 [RSABE / ABEL]: Helmut 17 days 10:03 ago
• CVintra in replicate designs (→ 2 IBDs) [General Sta­tis­tics]: Helmut 17 days 10:26 ago
• Intra Subject Variability [General Sta­tis­tics]: clinicalservices 17 days 12:45 ago
• 95% upper bound limit as per FDA for fully replicate crossover BE study [RSABE / ABEL]: dshah 17 days 12:58 ago
• 95% upper bound limit as per FDA for fully replicate crossover BE study [RSABE / ABEL]: yogeshla 17 days 14:03 ago
• Definition of Generic Drug in Mexico [Regulatives / Guidelines]: jag009 17 days 20:39 ago
• China DNS != Google DNS [Regulatives / Guidelines]: mittyri 17 days 22:48 ago
• China RSABE [Regulatives / Guidelines]: Helmut 18 days 05:15 ago
• IVIVC in R Tutorials [Dissolution / BCS / IVIVC]: Taonga Pomerai 18 days 06:18 ago
• HVD(P)s? [Regulatives / Guidelines]: 0521 18 days 08:54 ago

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Activity in the forum: 3 visitors (3 guests [including 2 identified bots]).