Quiz-Questions With Answers

Quiz-Questions with Answers
Q.1- What do you understand by Multidisciplinary guidelines? And in how

many sections it is divided.
Ans 1. Those are the cross-cutting topics which do not fit uniquely into one of the
Quality, Safety and Efficacy categories. It includes the ICH medical
terminology (MedDRA), the Common Technical Document (CTD) and the
development of Electronic Standards for the Transfer of Regulatory Information
(ESTRI). It includes total 15 sections.
Q.2-Four categories of ICH guidelines are _________.
Ans 2- Four categories are- Quality, Safety, Efficacy and Multidisciplinary.
Q.3- What do you understand by M2 guidelines and in which year it was
established and with what objective?
Ans 3- The M2 guideline is EWG Electronic standards for the transfer
of Regulatory Information and it was established by the ICH Steering Committee
in 1994 with the objective of facilitating international electronic communication
by evaluating and recommending, open and non-proprietary - to the extent possible
- Electronic Standards for the Transfer of Regulatory Information (ESTRI) that will
meet the requirements of the pharmaceutical companies and regulatory authorities.
Q.4- All eCTD submissions include ________ and it identifies following
information ____________.
Ans 4- Module 1 and and it identifies following information-1. Company name
2. Drug name
3. Submission Type
4. Submission date
5. Application number
6. Sequence Number
Q.5- M9 Biopharmaceutics Classification System (BCS) endorsed by the ICH
Assembly in __________.
Ans 5- October 2016
Q.6- The MedDRA (Medical Dictionary for Regulatory Activities) terminology
was launched in _______________________.
Ans-6- 1999
Q.7- What are the file formats that can be included in eCTD.
Ans 7- The files formats that can be included in the eCTD are portable document
format (PDF) and XML.
Q.8- In _______________, the ICH Steering Committee endorsed a Concept
Paper for Topic M5 and subsequently formed the M5 EWG to develop
ICH requirements for the standardization of medicinal product identifiers
and related terminology.
Ans 8- November 2003
Q.9- The Common Technical Document was agreed upon by the Steering
Committee in ___________.
Ans 9- November 2000
Q.10- The development of a Medical Dictionary for Regulatory Activities
(MedDRA) was approved by the ___________ in ___________.
Ans 10- ICH Steering Committee, 1997
Q. 11-What is objective of ICH?
Ans-ICH aims to achieve greater harmonisation worldwide for the
development and approval of safe, effective, and high-quality medicines in the
most resource-efficient manner.
Q 12- What is viral shedding in gene therapy?
Viruses are the most commonly used vectors for clinical gene therapy. The risk of
dissemination of a viral vector into the environment via excreta from the
treated patient, a phenomenon called shedding, is a major safety concern for the
environment.
Q 13- Explain M10 BIOANALYTICAL METHOD VALIDATION.

Ans-This topic was endorsed by the ICH Management Committee in October
2016.
• This new multidisciplinary guideline will apply to the validation of
bioanalytical methods and study sample analyses in non-clinical and clinical
studies.
• This guideline will provide recommendations on the scientific regulatory
requirements for bioanalysis conducted during the development of drugs of
both chemical and biological origins.
• It will also address issues on method validation by considering the
characteristics of the analytical methods used in bioanalysis, e.g.,
chromatographic assay and ligand binding assay.
Q 14. Explain M9 Biopharmaceutics Classification System (BCS)-based

biowaivers Guideline.
Ans- This topic was endorsed by the ICH Assembly in October 2016. This
new multidisciplinary Guideline is proposed to address
Biopharmaceutics Classification System (BCS)-based biowaivers.
• BCS-based biowaivers may be applicable to BCS Class I and III drugs,
however BCS-based biowaivers for these two classes are
not recognised worldwide.
• This Guideline applies to the systems supporting the development
and manufacture of pharmaceutical drug substances and drug products,
including biotechnology and biological products.
• This Guideline will provide recommendations to support the
biopharmaceutics classification of medicinal products and will provide
recommendations to support the waiver of bioequivalence studies.
Q 15. What is M10 testing?
Ans- The International Council for Harmonization of Technical Requirements
for Pharmaceuticals for Human Use (ICH) is in the process of revising M10, a
multidisciplinary guideline that governs bioanalytical method validation.
Drugs need to contain the correct concentrations of therapeutic products to be
effective and safe.
Q 16. What are the 3 types of drug interactions?
Ans- Drug-drug interaction: A reaction between two (or more) drugs.
• Drug-food interaction: A reaction between a drug and a food or beverage.
• Drug-condition interaction: A reaction that occurs when taking a drug while
having a certain medical condition.
Q 17. Explain ICH M13: Bioequivalence guidelines.

Ans- Supporting early-stage regulatory change-control, ie, changing the product
type during early clinical development.
• Supporting the use of blinding strategies in pivotal clinical studies, eg, the
use of over-encapsulated comparator products.

Quiz-Questions With Answers - ICH - Multidisciplinary Guidelines - Anurag

Uploaded by

Copyright:

Available Formats

Quiz-Questions With Answers - ICH - Multidisciplinary Guidelines - Anurag

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Quiz-Questions With Answers - ICH - Multidisciplinary Guidelines - Anurag

Uploaded by

Copyright:

Available Formats

Q.1- What do you understand by Multidisciplinary guidelines? And in how

Q 13- Explain M10 BIOANALYTICAL METHOD VALIDATION.

Q 14. Explain M9 Biopharmaceutics Classification System (BCS)-based

Q 17. Explain ICH M13: Bioequivalence guidelines.

You might also like