Drug Regulators, EMEA (EMA), Publish Draft Guidance on the Investigation of Bioequivalence.

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Organisations that commented on the draft Guideline as released for consultation

1 EFPIA
2 European Generic medicines Association (EGA)
3 EUFEPS Network on BABP
4 FIP Special Interest Group on BCS and Biowaiver
5 BPI-German Pharmaceutical Industry Association
6 The Association of the European Self Medication Industry (AESGP)
7 European Federation of Statisticians in the Pharmaceutical Industry
8 European Quality Assurance Confederation
9 International Association for Pharmaceutical Technology
10 BEBAC-Consultancy Services for bioequivalence and Bioavailability Studies
11 CIPLA LTD. INDIA
12 Pharmascience Inc. Montreal, Canada
13 Anapharm
14 Lupin Bioresearch Center
15 MANEESH PHARMACEUTICALS, LTD
16 MDS PHARMA SERVICES
17 POLFA TARCHOMIN S.A
18 PHAST GmbH
19 Jenson Pharmaceutical Services Ltd
20 Douglas Pharmaceuticals Ltd
21 Ratiopharm GmbH
22 Ranbaxy
23 Orion Corp. Orion Pharma
24 Gilead Sciences International Ltd
25 CEPHA s.r.o.
26 H.L. Lundbeck A/S
27 Combino-pharm
28 Bayer Schering Pharma AG/Clinical Pharmacology and Global Pharmacometrics
29 Quinta Analytica-s.r.o.
30 Hexal AG
31 Synthon BV
32 UCB Pharma S.A.
33 Merck Sharp & Dohme (Europe) Inc
34 ACC GmbH, Analytical Clinical Concepts

35 Slovak National Accreditation Service
36 Good Laboratory Practice Monitoring Authority
37 Norwegian Accreditation
38 Eye- Care Industries European Economic interest grouping
39 Dr. Nasir Idkaidek
40 Patrick Nicolas
41 Atholl Johnston
42 Laszlo Endrenyi
43 Aldo Rescigno
44 Carla M Catsmella
45 Salvador Fudio
46 Dr. Kamal K. Midha and Dr. Gordon McKay
47 Swissmedic

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