Contribute a Question?

"We request you to submit your favourite questions related to toxicology here"

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Q&A will be published below

 

The little girl who asks ' Why is the sky blue?' becomes the woman who changes the world"  

-  Sheryl Sandberg   

Improve an answer?

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Please refer Q&A from below section and submit your comments here

Q&A

              Please add your points using the above section  to improve the quality of an answer.

Q1:Toxicology of Herbal extracts, which will be an ideal guideline and why?

A 1: 

For evaluation of Safety Assessment of Herbal Extract, selection of appropriate guideline will depend on following :

 •Whether the information on ingredients/plant is available in Authentic books of Ayurveda, Unani, Siddha or not? 

•Whether the constituents of extract are well characterized, purified and standardized with defined minimum bio-active or phyto-chemical compounds or not 

•Country in which clinical trials to be conducted In India, for all formulations containing only such ingredients which are mentioned in the formulae described in the authoritative books of Ayurveda, Siddha and Unani Tibb system of medicine: AYUSH route of filing to be followed and relevant guidelines are " GENERAL GUIDELINES FOR SAFETY/TOXICITY EVALUATION OF AYURVEDIC FORMULATIONS" from CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES, Ministry of AYUSH, Govt, of India New Delhi. Web Link is http://www.ccras.nic.in/sites/default/files/viewpdf/Publication/CCRAS_Guideline%20of%20Safety_Toxicity.pdf. For Phytopharmaceuticals, i.e. purified and standardized fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals, the appropriate guidelines are “ Drug and Cosmetic Act” through DCGI route. Web Link is : https://upload.indiacode.nic.in/showfile?actid=AC_CEN_12_13_00023_194023_1523353460112&type=rule&filename=Drugs%20and%20Cosmetics%20Act,%201940%20and%20Rules,%201945.pdf Both the above mentioned guidelines are applicable for India filing . For filing in US the guideline to be followed is " Botanical Drug Development- Guidance for Industry" U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), December 2016, Pharmaceutical Quality/CMC, Revision 1. Web Link is https://www.fda.gov/media/93113/download 


( shahnaz.xxxxx@xxxxxxx.com )


Q2 : How could I derive NOAEL and LOAEL from dose-response data?

A:

Q3: What are the differences between Fetotoxicity, Teratogenicity and maternal toxicity?

A:

Q4:OECD guideline #423 used to test toxicity of a synthetic compound via intraperitoneal route?

A:

Q5: What kind of light source should be used while working with photosensitive chemicals?

A:

Q6: Do we need animal ethics permission to use zebra fish for screening drug safety?

A:

Q7 : What do you mean by Bench mark dose (BMD)?

A:

Q8: How many hours we can store Blood sample for hematology or Clinical chemistry analysis?

A:

Q9 : Do we need to add preservative to urine sample to avoid fermentation or unwanted odour?

A:

Q10 : Adaptive response is considered for Deriving NOAEL?

A:

Q11: What are the battery of Genotoxicity test?

A:

Q12 : What are parameters involved in FOB?

A:

Q13 : What are the various statistical tools in FOB analysis?

A:

Q14 : Adrenal weight is higher in female rats, if yes why?

A:

Q15 : If biochemical alterations which can be considered as adverse happens in main groups, but disappears in reversal groups, will it be considered for NOAEL?

A:

Q16 : What are the parameters considered for deriving MTD?

A:

Q17 : Acceptable limits in dose verification in respect to solution, Suspension, and Powder feed?

A:

Q18: Best definition for Toxicology?

A:

Q19: Why rat is considered better than Mouse for toxicology study?

A:

Q20 : What is difference between adverse response and adaptive response?

A:

Q21: Among six pack studies which is the first study to be conducted?

A:

Q22: Why requirement for acclimatisation is not mentioned in OECD 404 and 405 guideline?

A:

Q23: What are the parts of Study Plan?

A:

Q24: What are the parts of a Study Report?

A:

Q25 : What are the details to be included in a cage card?

A:

Q26 : What are the details to be mentioned in a vehicle label?

A:

Q27: Anti coagulation agents to be added in Blood for Clinical chemistry and Hematology analysis?

A:

Q27:Difference between Statistical , Biological and toxicological significant?

A:

Q28 : Gavage size for Mouse, rat and rabbit?

A:

Q29: Maximum dose volume in various animal species in various routes?

A:

Q30 : Differentiate irritation, corrosion and sensitization?

A:

Q31: Biomarkers for Hepatotoxicity?

A:

Q32: Biomarkers for Nephrotoxicity?

A:

Q33: Difference between Beuhler and GMPT methods?

A:

Q34: What is process based audit?

A:

Q35 : What is Segment I, II and Segment III studies?

A:

Q36: What is Ames Test?

A:

Q337: What is Chromosomal Aberration Assay ?

A:

Q38:  What is Mouse Lymphoma Assay in L5178Y Ttk+/- Cells?

A:

Q39: What is Micronucleus Assay in Human Lymphocyte?

A:

Q40: What is Sister Chromatid Exchange Assay?

A:

Q41: What are the steps involved in risk assessment?

A:

Q42: Differentiate PDE and OEL?

A:

Q43: What is meant by POD?

A:

Q44: Significance of knowing Pharmacokinetics of pharmaceuticals?

A:

Please add your points using the above section  to improve the quality of an answer.

Q45 : Differentiate zero order and first order reactions?

A:

Q46: What is a Medical Device?

A:

Q47: What are the Medical device Classification as per FDA ?

A:

Q48: Define Biocompatibility?

A:

Q49: What are the various biocompatibility Endpoints?

A:

Q 50: In a Toxicology Study, Increased clotting time can be correlated with?

A:

Q 51: Differentiate acute toxicity and repeated dose toxicity study?

A:

Q 52: Objectives of 28/90 day Repeated dose toxicity study?

A:

Q53: Significance of conducting acute toxicity study?

A:

Q 54: What is sparse sampling and continuous sampling in toxicokinetics?

A1:  Sparse sampling: blood sample will be collecting at different time points from the specified animals. Continuous sampling: blood sample will be collecting from all the animals from all time points. 

 ( malleshxx@gmail.com )  

Q 55: which eye will be selected for test item instillation in eye irritation study in rabbits

A1:

Right eye will be selected for test item instillation and left eye will act as control

( malleshxx@gmail.com

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A:

Q

A: