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Cmaxsant ☆ India, 2012-02-20 18:24 (5242 d 04:43 ago) Posting: # 8143 Views: 3,254 |
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Dear All Is there any specific precaution needs to be taken for performing Bioequivalence study for Light Sensitive Drug, any specific guidance available in this regard. Please share |
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Helmut ★★★   Vienna, Austria, 2012-02-20 18:40 (5242 d 04:27 ago) @ Cmaxsant Posting: # 8144 Views: 2,739 |
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Dear Cmaxsant! ❝ Is there any specific precaution needs to be taken for performing Bioequivalence study for Light Sensitive Drug, […] Counter question: What does common sense tell you? Please ![[image]](https://forum.bebac.at/img/search.png) search the forum in the future (this issue surfaces from time to time).❝ […] any specific guidance available in this regard. Not that I recall. — 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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Cmaxsant ☆ India, 2012-02-21 07:22 (5241 d 15:45 ago) @ Helmut Posting: # 8145 Views: 2,704 |
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Dear Helmut Schütz Common sense: other than the using appropriate precaution to avoid degradation while dosing/sampling & analysis. My concern is that many drugs are light sensitive, but they may have less sensitive (may negligible) - that can be justify by performing stability study analytically, even then do we need to perform the study in Light sensitive environment ?? |
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Helmut ★★★ Vienna, Austria, 2012-02-21 07:41 (5241 d 15:26 ago) @ Cmaxsant Posting: # 8146 Views: 2,737 |
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Dear Cmaxsant! ❝ Common sense: […] appropriate precaution to avoid degradation while dosing… Dosing? Have you read the linked posts (f.i. #752 and #2883)? Unless you are administering a drug as a slow infusion from a transparent bottle this should not be an issue. ❝ …/sampling & analysis. Sampling: What would you guess is the entry-depth of light into whole blood? Problems (may) start once you separated plasma/serum and during analysis. But this has to be validated anyway. ❝ My concern is that many drugs are light sensitive, but they may have less sensitive (may negligible) - that can be justify by performing stability study analytically, even then do we need to perform the study in Light sensitive environment ?? If you have validated your method from sampling to the final analysis, act accordingly. Sometimes no light protection is sufficient and sometimes only at specific steps (e.g., handling stock solutions and extracts). In my experience light protection in the clinical phase is like cracking a nut with a sledgehammer. — 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