Bioequivalence and Bioavailability Forum

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.

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