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Helmut
Hero
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Vienna, Austria,
2013-11-15 13:53

Posting: # 11890
Views: 6,787
 

 EMA: Q&A Update [BE/BA News]

Dear all,

yesterday EMA’s PK working party published Rev. 8 of the Q&A document.
New topics covered are:
  • Bioequivalence studies for generic application of omega 3 fatty acid ethylesters in a soft gelatine capsule.
  • Acceptability of an “additional strengths biowaiver” when bioequivalence to the reference product has been established with a BCS-based biowaiver.
  • Question on a generic application for Quetiapine Lambda 200, 300, 400 mg prolonged release tablets.
  • BCS classification of memantine.

Cheers,
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
luvblooms
Senior

India,
2013-11-16 06:36

@ Helmut
Posting: # 11896
Views: 5,926
 

 EMA: Q&A Update

Dear All

Yesterday EMEA has also published first set of product-specific bioequivalence guidance similar to that of FDA.
In the first set BE guidance of following products has been updated
  1. Capecitabine
  2. Carglumic acid
  3. Dasatinib
  4. Emtricitabine/tenofovir disoproxil
  5. Erlotinib
  6. Imatinib
  7. Memantine
  8. Miglustat
  9. Oseltamivir
  10. Posaconazole
  11. Repaglinide
  12. Sirolimus
  13. Sorafenib
  14. Tadalafil
  15. Telithromycine
  16. Voriconazole
Details of specific guidances could be found at this link http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000370.jsp&mid=WC0b01ac0580032ec5.

~A happy Soul~
Helmut
Hero
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Homepage
Vienna, Austria,
2013-11-16 12:20

@ luvblooms
Posting: # 11897
Views: 5,809
 

 The early bird gets the worm

Dear Luv & all

direct links and some first impressions already in this post. –14:51 :-D

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
luvblooms
Senior

India,
2013-11-16 14:23

@ Helmut
Posting: # 11898
Views: 5,848
 

 The early bird gets the worm but

Dear HS

The early bird gets the worm, BUT the second mouse gets the cheese...

Thanks for the explanation :ok:

But what does Lambda stands for in Quetiapine recommendation ???

:confused:

~A happy Soul~
Helmut
Hero
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Homepage
Vienna, Austria,
2013-11-16 15:25

@ luvblooms
Posting: # 11900
Views: 5,818
 

 Lambda Therapeutic Ltd.?

Hi Luv,

» But what does Lambda stands for in Quetiapine recommendation ???

I guess Noletil XL 200/300/400 mg Prolonged-release Tablets authorized for Lambda Therapeutic Ltd., North Harrow, UK.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
luvblooms
Senior

India,
2013-11-16 19:24
(edited by luvblooms on 2013-11-16 19:40)

@ Helmut
Posting: # 11901
Views: 5,800
 

 Lambda Therapeutic Ltd.?

Hey HS

They are a CRO I mean like in Clinical Research not in formulation development not even in contact research ;-)


But whatever it is, I am happy that finally EMEA realizes the pain of a formulator :cool:

~A happy Soul~
viveksraut
Junior

India,
2018-08-06 14:42

@ Helmut
Posting: # 19153
Views: 894
 

 EMA: Q&A Update; Expected studies for Quetiapine PR Tablets

Dear all,

This is with reference to the point no. 14 (Quetiapine Lambda) of “Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party (PKWP), EMA/618604/2008 Rev. 13” document published by EMA on 19 November 2015 )” to address specific questions in relation to pharmacokinetic evaluations and particularly the requirements and assessment of bioequivalence studies.

From the PKWP response to the point no. 14 question I understand the following;
  • For Quetiapine Lambda 200, 300, 400 mg prolonged release tablets, because of safety issue in healthy subjects, single dose study under fasting and fed conditions with 200 mg strength in healthy volunteers and a multiple-dose study with the highest, 400 mg tablet in schizophrenic patients are considered adequate from clinical point of view.

  • Waiver of multiple dose studies for the 200 mg and 300 mg strengths can be granted based on conditions applicable to IR forms as per BE GL currently in force.

  • Waiver of single dose studies for the 300 mg and 400 mg studies is considered acceptable as single dose studies are not feasible both in healthy volunteers and patients

So if applicant is developing generic version of Quetiapine prolonged release tablets and intended strengths are 25mg, 100mg, 200mg and 300 mg. Then in view of the PKWP response on this product and taking into account the guidance on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), 20 Nov 2014, what are the studies expected by EMA for this product ? Your opinion please on this.

Regards : Vivek
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