- Dissolution Testing Requirement - ANDA jag009 2019-10-30 02:29
- If method doesn't exist in FDA Disso Database jag009 2019-10-24 20:54
- USP should be fine Helmut 2019-10-25 00:33
- USP should be fine jag009 2019-10-30 02:23
- USP should be fine Helmut 2019-10-25 00:33
- Dissolution Media for Comparative Dissolution Study ilee9009 2019-09-20 11:00
- predicting in vivo PK profiles from in vitro data after establishing IVIVC amer 2019-09-09 05:04
- external predictability for ivivc yjlee168 2019-09-09 10:46
- external predictability for ivivc amer 2019-09-10 02:31
- identical pH Helmut 2019-09-10 10:58
- identical pH yjlee168 2019-09-10 15:30
- R scripts/codes for in-vivo conc. yjlee168 2019-09-10 15:13
- Software validation, another round Helmut 2019-09-10 15:37
- Deconvolution mittyri 2019-09-10 15:54
- Software validation, another round yjlee168 2019-09-11 10:29
- Software validation, another round Helmut 2019-09-11 13:39
- Software validation, another round amer 2019-09-12 05:26
- Should we also consider to validate the validation? yjlee168 2019-09-12 09:46
- Who inspects the inspectors? Helmut 2019-09-13 12:07
- Who inspects the inspectors? nobody 2019-09-13 12:55
- Sapienti sat Helmut 2019-09-13 12:59
- Who inspects the inspectors? nobody 2019-09-13 12:55
- Who inspects the inspectors? Helmut 2019-09-13 12:07
- Should we also consider to validate the validation? yjlee168 2019-09-12 09:46
- Software validation, another round amer 2019-09-12 05:26
- Software validation, another round Helmut 2019-09-11 13:39
- R scripts/codes for in-vivo conc. amer 2019-09-11 05:35
- Bioavailabity term in predicted in-vivo conc. yjlee168 2019-09-11 10:16
- Software validation, another round Helmut 2019-09-10 15:37
- identical pH Helmut 2019-09-10 10:58
- external predictability for ivivc amer 2019-09-10 02:31
- external predictability for ivivc yjlee168 2019-09-09 10:46
- Biorelevant Dissolution - FeSSGF with Ensure Plus thalita_m 2019-07-26 15:55
- BSC approach at each strength? Mauricio Sampaio 2019-07-19 22:29
- BSC approach at each strength? jag009 2019-07-22 19:56
- BSC approach at each strength? Mauricio Sampaio 2019-07-22 21:43
- BSC approach at each strength? Ohlbe 2019-07-22 23:58
- BSC approach at each strength? Mauricio Sampaio 2019-07-23 04:48
- BCS approach at each strength? Mauricio Sampaio 2019-07-26 15:32
- BSC approach at each strength? Mauricio Sampaio 2019-07-23 04:48
- BSC approach at each strength? Ohlbe 2019-07-22 23:58
- BSC approach at each strength? Mauricio Sampaio 2019-07-22 21:43
- BSC approach at each strength? jag009 2019-07-22 19:56
- Statistical comparison of dissolution profiles - variable nr of units MSimoes 2019-07-17 18:13
- Statistical comparison of dissolution profiles - variable nr of units ElMaestro 2019-07-17 21:02
- Statistical comparison of dissolution profiles - variable nr of units MSimoes 2019-07-18 10:22
- EU: No Mahalanobis Helmut 2019-07-18 13:06
- Statistical comparison of dissolution profiles - variable nr of units ElMaestro 2019-07-17 21:02
- IVIVC with Bioequivalence Data thalita_m 2019-06-18 01:55
- IVIVC or not IVIVC? yjlee168 2019-06-18 20:57
- IVIVC or not IVIVC? thalita_m 2019-06-20 22:40
- Get Fabs if no iv data... yjlee168 2019-06-19 09:36
- IVIVC or not IVIVC? yjlee168 2019-06-18 20:57
- Is FDA dissolution database more preferable to product specific FDA BE guidance? yuvaneshwari 2019-04-18 11:12
- Is FDA dissolution database more preferable to product specific FDA BE guidance? Vineeth KE 2019-04-25 13:15
- BCS II waiver approach yuvaneshwari 2019-01-23 06:09
- Solubility Testing-Shake flask method ramgopi 2018-12-03 13:30
- BCS Biowaiver for oral suspension averroes1304 2018-11-19 21:14
- BCS Biowaiver for oral suspension Mauricio Sampaio 2018-11-23 15:39
- BCS Biowaiver for oral suspension wienui 2018-11-23 19:36
- BCS Biowaiver for oral suspension Mauricio Sampaio 2018-11-26 18:17
- BCS Biowaiver for oral suspension wienui 2018-11-27 03:50
- BCS Biowaiver for oral suspension Mauricio Sampaio 2018-11-26 18:17
- EMA: Mahalanobis distance is dead... Helmut 2018-11-09 18:01
- EMA: Mahalanobis distance is dead... ElMaestro 2018-11-09 19:12
- Is ƒ2 dead as well – always bootstrapping? Helmut 2019-10-06 15:27
- Is ƒ2 dead as well – always bootstrapping? ElMaestro 2019-10-06 17:54
- Ahem – number of units? Helmut 2019-10-06 18:14
- Ahem – number of units? ElMaestro 2019-10-06 22:45
- Ahem – number of units? wienui 2019-10-07 19:11
- Ahem – number of units? elba.romero 2021-10-28 00:08
- Ahem – number of units - ICH M9 Relaxation 2021-10-28 16:20
- Ahem – number of units? ElMaestro 2019-10-06 22:45
- Ahem – number of units? Helmut 2019-10-06 18:14
- Is ƒ2 dead as well – always bootstrapping? ElMaestro 2019-10-06 17:54
- Is ƒ2 dead as well – always bootstrapping? Helmut 2019-10-06 15:27
- EMA: Mahalanobis distance is dead... ElMaestro 2018-11-09 19:12
- Class I BCS based biowaiver with different amounts of API between T and R joosefupas 2018-11-08 11:00
- Class I BCS based biowaiver with different amounts of API between T and R Obinoscopy 2018-11-10 08:25
- Class I BCS based biowaiver with different amounts of API between T and R joosefupas 2018-11-12 09:49
- Class I BCS based biowaiver with different amounts of API between T and R Obinoscopy 2018-11-10 08:25
- BCS Based Biowaiver application Price? joosefupas 2018-10-19 14:54