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ssk ● 2006-08-14 11:27 (6457 d 23:55 ago) Posting: # 211 Views: 8,814 |
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sir, can you please explain me which is called a pilot study and which is called a pivotal study and on which basis are they classified? |
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Helmut ★★★   Vienna, Austria, 2006-08-14 11:45 (6457 d 23:36 ago) @ ssk Posting: # 212 Views: 7,985 |
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Hello ssk! Quoting Duke CRI: Pivotal study: A study, usually Phase III, that presents the data used by FDA to decide whether to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. Pilot study: A small study conducted in advance of a large one, to test the feasibility of the large study or various doses of the study drug. In the BE setting, the main purpose of a pilot study is sample size estimation (since the pharmacokinetics of the drug generally are already well known). — 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 |
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Ahmed meeran ● 2006-08-16 14:02 (6455 d 21:19 ago) @ Helmut Posting: # 217 Views: 7,549 |
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Dear MR Helmut, Suppose if we conduct a Pilot Bioequivalence study with no. of subject as 12, and if the Biostudy passes the acceptance criteria; can we submitt the same data to the regulatory authorities, instead of going for a pivotal study. (for eg MCC SA min req of sub. is 12 only). Could u please throw some light on this. With regards, D.Ahmed |
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Helmut ★★★ Vienna, Austria, 2006-08-16 14:44 (6455 d 20:37 ago) @ Ahmed meeran Posting: # 218 Views: 7,716 |
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Dear Ahmed, first have a look at Hermann's post. It should be possible to claim BE with a pilot study, if
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Essar ● 2006-11-17 06:48 (6363 d 03:33 ago) @ Helmut Posting: # 365 Views: 7,466 |
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❝ Pilot study: A small study conducted in advance of a large one, to test the feasibility of the large study or various doses of the study drug. ❝ ❝ In the BE setting, the main purpose of a pilot study is sample size estimation (since the pharmacokinetics of the drug generally are already well known). Dear All: Normally Pilot BE studies are done on small batches prepared at R&D and R&D's are normally not GMP-compliant. Is that OK? We also understand that data from these pilot studies are not submitted to Regulatory bodies. Regards, Essar |
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Helmut ★★★ Vienna, Austria, 2006-11-17 13:19 (6362 d 21:02 ago) @ Essar Posting: # 366 Views: 7,587 |
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Hello Essar! ❝ Normally Pilot BE studies are done on small batches prepared at R&D and R&D's are normally not GMP-compliant. Is that OK? Not normally, but also  If you want to perform a pilot study for e.g. sample size estimation, your test product should originate from a batch of at least 1/10 of production scale or 100 000 units, whichever is larger (according to EU-regulations). ❝ We also understand that data from these pilot studies are not submitted to Regulatory bodies. Again, it depends… You will have to get an approval of the protocol (e.g., USA, EU,…). If you perfom a pivotal study afterwards, at least you must - briefly - report the outcome of the pilot study in the protocol (because your study design relies on it). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz