Log in
RegisterAnd Japan? [BE/BA News]
Wow,
» A: The guideline focuses on BCS-based biowaiver principles to be applied for bioequivalence purposes provided they are supported by a sound scientific rationale. The provision in the guideline that accommodates exceptions to existing regulations that do not permit BCS-based biowaivers for generic product applications, at this time, does not disqualify implementation of these harmonized technical requirements to demonstrate BCS based biowaivers for other product applications unless explicitly stated.
I tried to read that answer 10 times now and I am none the wiser. Do they mean "The guideline will deal with BCS-based biowaivers, but it is acknowledged that some countries might not accept those." ??
» A: The guideline focuses on BCS-based biowaiver principles to be applied for bioequivalence purposes provided they are supported by a sound scientific rationale. The provision in the guideline that accommodates exceptions to existing regulations that do not permit BCS-based biowaivers for generic product applications, at this time, does not disqualify implementation of these harmonized technical requirements to demonstrate BCS based biowaivers for other product applications unless explicitly stated.
I tried to read that answer 10 times now and I am none the wiser. Do they mean "The guideline will deal with BCS-based biowaivers, but it is acknowledged that some countries might not accept those." ??
—
I could be wrong, but...
Best regards,
ElMaestro
R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.
I could be wrong, but...
Best regards,
ElMaestro
R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.
Complete thread:
- ICH M13 Helmut 2019-11-27 19:08 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH M13 ElMaestro 2019-11-27 21:42
- ICH pushed by GBHI? Helmut 2019-11-28 12:37
- ICH pushed by GBHI? Ohlbe 2019-11-28 14:06
- “Lively” discussions Helmut 2019-11-28 14:23
- M9 step 4 now published Ohlbe 2019-12-04 11:26
- And Japan? Helmut 2019-12-04 11:42
- And Japan?ElMaestro 2019-12-04 14:43
- 🈴 business as usual Helmut 2019-12-04 15:42
- And Japan?ElMaestro 2019-12-04 14:43
- And Japan? Helmut 2019-12-04 11:42
- M9 step 4 now published Ohlbe 2019-12-04 11:26
- “Lively” discussions Helmut 2019-11-28 14:23
- ICH pushed by GBHI? Ohlbe 2019-11-28 14:06
- ICH pushed by GBHI? Helmut 2019-11-28 12:37
- ICH M13 ElMaestro 2019-11-27 21:42
Ing. Helmut Schütz