Literature Safety Monitoring

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Literature Safety Monitoring

Рет қаралды 5,837

VigiServe Academy for Patient Safety

Күн бұрын

Learn about the literature search and review process in Pharmacovigilance.
www.pubmed.gov
Search String:
DRUG NAME AND ('adverse drug reaction'/exp OR 'adverse drug reaction' OR 'drug overdose'/exp OR 'drug overdose' OR 'drug misuse'/exp OR 'drug misuse' OR 'drug abuse' OR 'substance abuse'/exp OR 'substance abuse' OR 'pregnancy'/exp OR 'pregnancy' OR 'drug efficacy'/exp OR 'drug efficacy' OR 'drug withdrawal'/exp OR 'drug withdrawal' OR 'drug tolerance'/exp OR 'drug tolerance' OR 'medication error'/exp OR 'medication error' OR 'death'/exp OR 'death' OR 'drug interaction'/exp OR 'drug interaction' OR 'carcinogenicity'/exp OR 'carcinogenicity' OR 'off label drug use'/exp OR 'off label drug use' OR 'occupational exposure'/exp OR 'occupational exposure' OR 'toxicity'/exp OR 'intoxication' OR 'drug contraindication'/exp OR 'drug contraindication' OR 'congenital disorder'/exp OR 'congenital disorder' OR 'drug treatment failure'/exp OR 'drug treatment failure' OR 'lactation'/exp OR 'lactation' OR 'case report'/exp OR 'case report' OR 'environmental exposure'/exp OR 'environmental exposure' OR 'treatment contraindication'/exp OR 'treatment contraindication')

Пікірлер: 25

@chessgold8768 Ай бұрын

great and very instructive sir.. thanks a lot..

@avbviswanath 2 жыл бұрын

Thanks for the videos, new scope of learning

@Sanket_2202 Жыл бұрын

Thank you so much sir. It would really help in my interviews😃.

@mudassirsheikh3970 2 жыл бұрын

Thanks for your efforts and conviniance

@Praveenkumarvarungowda85 Жыл бұрын

Wonderful explanation of Literature screening... Thank you😊

@YogeshJadhav-qm2zb Жыл бұрын

Amazing video. So much of learning👍

@jenisharon1076 11 ай бұрын

It was very informative sir.. Thank u so much..

@anupreetkang3475 5 ай бұрын

Thanks so much for a detailed video on lit screening for ICSRs. Don't we consider a related/possible causality for a literature article to be valid along with the 4 min criteria?

@VigiServeAcademy 5 ай бұрын

Yes, you can consider Author's causality

@riajuli3 2 жыл бұрын

Very useful Thanks.

@nitinpawar9182 2 ай бұрын

Need to understand the process for literature review for the product marketed in INDIA. We are doing literature review through 2 website Indian Pharmacology and Dermatology sites

@VigiServeAcademy 2 ай бұрын

There is no point if these are indexed journals. Look for grey literature or journals published by various organizations (e.g., colleges)

@SandeepSingh-ci5cf Жыл бұрын

Really Great lesson for Literature Triage, However This was only for ICSR, could you kindly make a lecture on the process of Literature Triage process for aggregate/PSUR. Explain 10 Criteria points for PSUR triage.

@VigiServeAcademy Жыл бұрын

Thanks, Sandeep. Yes, we will consider this in the future.

@0602ify Жыл бұрын

For drugs that are on clinical trails, how do we do literature search? Using comparator drugs and what do we look for?

@VigiServeAcademy Жыл бұрын

You can even look for emerging safety issues with the class of drugs

@ksravanthi-ge3bg Жыл бұрын

Thank you sir....

@prakash-xb8ck 10 ай бұрын

Very good session

@ravitejasambu8533 Жыл бұрын

As per the USFDA guidelines we search with only the active ingredient irrespective of drug dose, dosage form and strength of the drug as you have covered only regarding the EU guidelines is it true sir

@VigiServeAcademy Жыл бұрын

yes, we have primarily covered the EU/EEA or the GVP VI guideline. The FDA guidelines (the document that talks about this briefly is still in draft) are not very clear in this regard and hence companies prefer a conservative approach.