Log in
Register|
devender_naik ☆ Hyderabad, 2007-01-14 16:20 (6695 d 22:20 ago) Posting: # 465 Views: 4,473 |
|
|
Dear all can any please let me know, whether there is any specific procedure for dispensing of drugs as per any regulatory guidelines in a BA/ BE study. regards dev |
|
Helmut ★★★   Vienna, Austria, 2007-01-14 16:47 (6695 d 21:53 ago) @ devender_naik Posting: # 466 Views: 3,723 |
|
|
Dear dev, a detailed starter is Annex 9, Section 14 (Receiving, storage and handling of investigational drug products) of the WHO's Fortieth Report (WHO Technical Report Series No. 937). Furthermore in many countries you have to follow local laws regarding GCP [e.g., for India: 2.3.1.6. Handling of the Product(s)]. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
paresh.mistry ● 2007-01-16 06:50 (6694 d 07:51 ago) @ devender_naik Posting: # 469 Views: 3,466 |
|
|
dear dev, you should handle the IP as per finish product GMP requirement and should follow the description of drug literature for the dispensing. ideally there is no specific guideline as such published for clinical research dispensing but follow GMP for the dispenising is safe way. regards, paresh |
Ing. Helmut Schütz