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Register- Biowaiver for lower strength using different OGD media dshah 2020-07-13 08:09
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- EMA: No biowaivers for NTIDs Helmut 2020-07-15 19:08
- EMA: No biowaivers for NTIDs Relaxation 2020-07-16 10:54
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs Helmut 2020-07-16 11:27
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs Obinoscopy 2020-07-16 14:36
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs dshah 2020-07-17 06:27
- Additional Strength Biowaiver Requirements Obinoscopy 2020-07-18 03:13
- Additional strength Biowaiver wienui 2020-07-18 18:00
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs dshah 2020-07-17 06:27
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs Obinoscopy 2020-07-16 14:36
- Biowaiver only for BCS I and – under certain conditions – BCS III drugs Helmut 2020-07-16 11:27
- EMA: No biowaivers for NTIDs Relaxation 2020-07-16 10:54
- EMA: No biowaivers for NTIDs Helmut 2020-07-15 19:08
- how to use Loo Riegelman method and deconvolution laili 2012-05-07 09:40
- how to use Loo Riegelman method and deconvolution SDavis 2012-05-18 12:32
- how to use Loo Riegelman method and deconvolution vjkumar 2012-08-23 12:03
- how to use Loo Riegelman method and deconvolution Gobardhan 2020-07-16 13:31
- 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 Abel1972 2020-06-17 05:28
- 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. Achievwin 2020-06-17 15:00
- 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
- Weibull method for Dissolution Similarlies Jainee 2020-04-30 18:10
- Weibull method for Dissolution Similarlies yjlee168 2020-04-30 18:31
- Weibull method for Dissolution Similarlies Nirali 2020-05-01 07:37
- Weibull method for Dissolution Similarlies Achievwin 2020-05-07 03:49
- Weibull method for Dissolution Similarlies Jainee 2020-05-10 11:35
- Weibull method for Dissolution Similarlies yjlee168 2020-04-30 18:31
- Comp in-vitro disso studies for generics in India jag009 2020-03-12 15:41
- Comp in-vitro disso studies for generics in India ping4santosh 2020-03-12 19:18
- Comp in-vitro disso studies for generics in India jag009 2020-03-13 17:34
- Comp in-vitro disso studies for generics in India ping4santosh 2020-03-14 23:20
- Comp in-vitro disso studies for generics in India jag009 2020-03-15 07:25
- Comp in-vitro disso studies for generics in India ping4santosh 2020-03-15 10:05
- Comp in-vitro disso studies for generics in India jag009 2020-03-15 07:25
- Comp in-vitro disso studies for generics in India ping4santosh 2020-03-14 23:20
- Comp in-vitro disso studies for generics in India jag009 2020-03-13 17:34
- Comp in-vitro disso studies for generics in India ping4santosh 2020-03-12 19:18
- Glycopyrrolate BCS Class AB661 2020-01-29 10:12
- Glycopyrrolate BCS Class Achievwin 2020-02-04 23:17
- Bio-waiver of Sapropterin dihydrochloride powder for oral solution AB661 2019-11-22 17:49
- 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
Ing. Helmut Schütz