Hong Doi

9 Questions 13 Answers 0 Followers

Questions related from Hong Doi

Future of Nanomaterials/Nanotechnology?

Dear all, I am now doing a Master's degree in Pharmaceutical science and after that, I want to pursue a PhD degree in Nanomaterials (to be more specific: Antimicrobial polymers and hydrogels). I...

22 May 2018 1,905 4 View

How to choose properly adjustment factors for PDE calculation?

I try to calculate PDE for cefdinir based on the results of reproduction and developmental toxicity studies as in the attachment. According to EMA guideline, the equation used to calculate PDE...

10 May 2018 6,104 2 View

How to identifying NOEAL/LOAEL basing on the data of toxicological studies?

According to EMA guideline, the PDE ( permitted daily exposure) is calculated by dividing NOAEL/LOAEL value by some safety factors. My problem is how to identify the NOAEL/LOAEL basing on the...

20 April 2018 533 1 View

Is it necessary to do the validation of analytical procedure when changing the solvent used to prepare samples?

In USP 37, Cefdinir is assayed by HPLC and the phosphate buffer solution ( pH=7) is used to dissolve the subtance. Now, I want to study the degradation of cefdinir in basic solution ( using 5%...

13 April 2018 2,065 18 View

How to determine the LOQ and LOD for a LC/MS/MS assay method?

I know that there are several method to determine limit of detection and limit of quantitation such as calibration method, signal-to-noise method. For example, the author of the article below...

26 March 2018 6,214 4 View

Limit of residual beta-lactams in drugs and food?

Is there any offical document where I can find the regulation on the limit of residual beta-lactams in drugs and food? I have already read FDA cGMP and also EU GMP but I couldn't find any clear...

13 March 2018 3,019 5 View

Using Delvotest SP NT to control beta lactam trace in penicillin manufacturing plants?

Delvotest SPNT is designed to test milk for the presence of antibacterial substances. I wonder if we can use this test kit to detect beta lactam trace in samples such as waste water, emission or...

08 March 2018 9,008 2 View

How to calculate PDE ( permitted daily exposure) for antibiotics such as penicillins and cephalosporins?

According to EMA guideline on setting health based exposure limits, to calculate PDE for a specific substance, we have to establish NOEAL or LOEL. However, there is no available data of NOEAL or...

13 February 2018 6,874 15 View

How to choose critical effects to establish NOAEL?

Hi everybody, I am working with the EMA guideline on setting health based exposure limits. The procedure to calculate permitted daily exposure ( PDE) includes: (i) hazard identification by...

08 February 2018 4,623 1 View