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chiragkhatri ★ India, 2008-11-21 14:52 (6071 d 21:26 ago) Posting: # 2766 Views: 7,890 |
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Dear members, I would like to know what could be the impact on a Fed study when one volunteer has consumed 200 Kcalories less than the actual consumption of 930 Kcal (as per Protocol). Knowing this fact also the volunteer was continued for the study. The drug under study is a highly variable drug (a proton pump inhibitor class). How to address this situation when filing a protocol deviation. In anticipation of your valuable comment. Thanks Chirag khatri |
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Sasi ☆ 2008-11-22 07:41 (6071 d 04:37 ago) @ chiragkhatri Posting: # 2772 Views: 6,508 |
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Dear Chirag khatri, As per my concern it is depend on the investigator's decision, he can continue him in the study, but the investigator should address deviation and justification (Literatures) for the deviation should be provided. Regards sasi |
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sumatha balusu ● 2008-11-27 10:48 (6066 d 01:30 ago) (edited on 2008-11-28 08:45) @ chiragkhatri Posting: # 2813 Views: 6,455 |
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❝ I would like to know what could be the impact on a Fed study when one volunteer has consumed 200 Kcalories less than the actual consumption of 930 Kcal (as per Protocol). Knowing this fact also the volunteer was continued for the study. How to address this while filing a protocol deviation. Hi, You need to consider both the guidelines and protocol before addressing such a deviation, since you need to give a justification for the same. As per the guidelines "high-calorie (approximately 800 to 1000 calories) meal is recommended as a test meal for food-effect BA and fed BE studies but all depends on what has been mentioned in the protocol". Since there is only one volunteer has consumed less calories we can address the deviation along with the justification on what situation he didnot consume. |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-27 11:42 (6066 d 00:36 ago) @ sumatha balusu Posting: # 2814 Views: 6,445 |
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Dear Chirag and Sumatha, If the volunteer consumes 200 cal leas the same can be documented as protocol deviation. Secondly in the food distribution form we can document how much and what the volunteer not consumed. Accordingly consumed cal can be calculated. ❝ address the deviation along with the justification on what situation he didnot consume. I am confused weather we can justify the situation or not  It's not a general practice or guideline never expects you to do so Yes..! volunteer can be allowed with the study (PI's decission...!) Depending upon the uncosumed food total cal can be calulted. It may or it may not create an impact on PK depending upon molecule Regards, Joshi — Best Regards Joshi |
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sumatha balusu ● 2008-11-27 13:32 (6065 d 22:46 ago) (edited on 2008-11-28 08:46) @ chidambarajoshi Posting: # 2817 Views: 6,321 |
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Dear Chidambara Joshi ❝ I am confused weather we can justify the situation or not, It's not a general practice or guideline never expects you to do so Yes u need to mention the deviation and accordingly record the reason for the same. It should reflect why the intake got reduced because it might be due to some reason that he had consumed less. |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-27 13:41 (6065 d 22:37 ago) @ sumatha balusu Posting: # 2819 Views: 6,369 |
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Dear Sumatha ❝ It should reflect why the intake got reduced because it might be due to any adverse effect that he might have consumed less. Adverse event can only occur post dose. But in fed study food is fed first and later (after 20 mins) volunteer is dosed ❝ Anyway this will not affect much IMHO no..!  Regards Joshi — Best Regards Joshi |
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sumatha balusu ● 2008-11-28 08:06 (6065 d 04:12 ago) (edited on 2008-11-28 08:43) @ chidambarajoshi Posting: # 2826 Views: 6,366 |
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Dear Chidambara Joshi, ❝ Adverse event can only occur post dose. But in fed study food is fed first and later (after 20 mins) volunteer is dosed If you can get into the query from Chirag the volunteer has already been continued for the study later they have observed and would like to addess the issue.  What I meant was, what made him consume less calories than others?Regards Sumatha |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-28 13:56 (6064 d 22:22 ago) @ sumatha balusu Posting: # 2831 Views: 6,306 |
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Dear Sumatha ❝ what made him consume less calories than others? I don’t think this makes any sense in fed study. Yes..! it needs a documentation saying this much food was not consumed to caculte the total cals cosumed. Food intake matters incase of absorption of proton pump inhibitors. B’coz proton pump inhibitors are less absorbed (apprx< 50%) in presence of food. Regards, Joshi — Best Regards Joshi |
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sumatha balusu ● 2008-12-09 09:39 (6054 d 02:39 ago) @ chidambarajoshi Posting: # 2895 Views: 6,186 |
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❝ it needs a documentation saying this much food was not consumed to caculte the total cals cosumed. That's what I wanted to convey that it need to be documented Mr Chidambara Joshi. There is no point in discussing for such a long on this topic, it will not take us anywhere...........  All the best for your future.......... |
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