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Register- Bio-waiver of Sapropterin dihydrochloride powder for oral solution AB661 2019-11-22 17:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Please do your homework first Helmut 2019-11-24 10:51
- Bio-waiver of Sapropterin dihydrochloride powder for oral solution Achievwin 2019-12-03 17:06
- 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
- 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? 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
- 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
- Virtual Bioequivalence: a myth or coming reality? mittyri 2018-06-09 22:39
- Virtual Bioequivalence: a myth or coming reality? jag009 2018-06-13 02:40
- Virtual Bioequivalence: a myth or coming reality? elba.romero 2018-10-19 01:17
- Virtual Bioequivalence: an update from PAGE (+TSD!) mittyri 2019-06-21 13:50
- FDA not concerned about the type I error? Helmut 2019-06-22 18:11
- 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
- IVIVC calculations mahendra 2013-10-24 16:10
- IVIVC calculations yjlee168 2013-10-24 19:22
- IVIVC calculations mahendra 2013-10-24 19:45
- IVIVC calculations yjlee168 2013-10-24 22:21
- Mergers Helmut 2013-10-25 14:38
- IVIVC calculations mahendra 2013-10-25 16:49
- PCDCON ⇒ IVIVC calculations yjlee168 2013-10-27 05:41
- IVIVC calculations thalita_m 2019-06-18 02:51
- IVIVC calculations yjlee168 2013-10-24 22:21
- IVIVC calculations mahendra 2013-10-24 19:45
- IVIVC calculations jag009 2013-10-24 23:17
- Minitab etc. Helmut 2013-10-25 14:43
- Minitab etc. jag009 2013-10-25 16:27
- XL Helmut 2013-10-25 16:38
- XL jag009 2013-10-28 20:42
- XL luvblooms 2013-10-29 05:08
- XL jag009 2013-10-29 15:07
- XL luvblooms 2013-10-30 07:00
- Broken link Helmut 2013-10-30 14:40
- XL jag009 2013-10-30 16:35
- XL luvblooms 2013-10-31 08:15
- XL jag009 2013-10-31 20:31
- Any news? jag009 2013-11-06 16:44
- Good News luvblooms 2013-11-07 10:50
- PBPK IVIVC jag009 2013-11-27 16:44
- PBPK IVIVC luvblooms 2013-11-27 19:31
- PBPK IVIVC jag009 2013-11-27 20:04
- PBPK IVIVC luvblooms 2013-11-27 19:31
- Good News jag009 2013-11-28 06:01
- PBPK IVIVC jag009 2013-11-27 16:44
- Contact Helmut 2013-11-07 14:50
- Contact jag009 2013-11-27 16:42
- Good News luvblooms 2013-11-07 10:50
- XL luvblooms 2013-10-31 08:15
- XL luvblooms 2013-10-30 07:00
- XL jag009 2013-10-29 15:07
- XL thalita_m 2019-06-18 02:46
- Jean-Michel Helmut 2019-06-18 11:08
- Jean-Michel thalita_m 2019-06-20 22:18
- Jean-Michel Helmut 2019-06-18 11:08
- XL luvblooms 2013-10-29 05:08
- XL jag009 2013-10-28 20:42
- XL Helmut 2013-10-25 16:38
- Minitab etc. jag009 2013-10-25 16:27
- IVIVC calculations mahendra 2013-10-25 16:48
- Minitab etc. Helmut 2013-10-25 14:43
- IVIVC calculations vinayshed 2013-10-28 08:54
- IVIVC calculations yjlee168 2013-10-24 19:22
- 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
- Dissolution similarity Nirali 2010-11-10 11:13
- Dissolution similarity Nirali 2011-04-21 12:27
- Dissolution similarity Aceto81 2011-04-28 15:14
- Mahalanobis distance - R code d_labes 2011-04-29 15:14
- Dissolution similarity Aceto81 2011-04-28 15:14
- DDSolver, Mahalanobis distance and its 90% CI yicaoting 2011-10-06 16:03
- DDSolver, Mahalanobis distance and its 90% CI Nirali 2012-07-03 07:40
- DDSolver, Mahalanobis distance and its 90% CI d_labes 2012-07-06 10:54
- DDSolver, Mahalanobis distance and its 90% CI Sid 2019-03-07 19:23
- Dissolution similarity Nirali 2011-04-21 12:27
- BCS II waiver approach yuvaneshwari 2019-01-23 06:09
Ing. Helmut Schütz