Term
| Marketing Authorization Holders are also called .......... |
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Definition
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Term
| CTD document is mandatory in which countries |
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Definition
EU, Japan - mandatory
US, Canada, Australia - highly recommended |
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Term
| M4Q guidance in ICH guidelines applies to which section of the CTD application? |
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Definition
Quality data
Chemical and Pharmaceutical data |
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Term
| M4E guidance is responsible for which section of the CTD application? |
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Definition
| Efficacy - Clinical section |
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Term
| M4S guidance is responsible for which section of the CTD application? |
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Definition
| Safety_ Non-clinical section |
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Term
| Which module of the CTD application contains "region specific" information |
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Definition
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Term
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Definition
| High level summaries and overviews of quality, non-clinical and clinical data. |
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Term
Detailed non-clinical data related to drug/biologic should be included in the following sections.
1. Module 2
2. Module 5
3. Module 3
4. Module 4 |
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Definition
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Term
ICH does not yet have guidelines on impurities in drug product.
True or False |
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Definition
False.
ICH guideline on impurities (Impurities in New Drug Substances Q3A(R2)) |
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Term
The section on Drug substance (Module 3) will not include the following data:
1. Process validation
2. Control of drug substance
3. Dosage form and formulation
4. Container closure system |
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Definition
Dosage form and formulation.
It is included in section on Drug Product. |
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Term
True or False
Drug substance part of the quality documentation in the CTD (section 3.2S) contains information related to the Active Phamaceutical Ingredient (API) |
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Definition
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Term
Details of in-vitro/in-vivo PK/PD and toxicology studies will be included in
1. Module 4
2. Module 3
3. Module 5 |
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Definition
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Term
| Antigenicity and immunotoxicity studies will be included in which module of CTD? |
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Definition
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Term
InVivo Pharma has a biologic approved for Gaucher's disease on the market. It decides to change the manufacturer of this product. What kind of notification does it need to provide if any?
1. A full standalone application
2. An abridged application
3. 505 (b)2 |
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Definition
| A full standalone application |
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Term
InVivo Pharma has discovered a chemical entity which is essentially similar to a chemical entity already approved in EU. Which kind of application will it file?
1. Standalone full application
2. Abridged application |
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Definition
Abridged
Since the chemical entity is essentially similar |
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Term
| Herbal medicines need an abridged application |
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Definition
False.
Simple registration required in most countries. |
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Term
InVivo Pharma has a found a chemical entity that is on the market for 20 years and there is no reference medicinal product to which essential similarity can be claimed. What studies does it need to conduct? Note: The indication proposed for this chemical entiry is the same.
1. Pharmacological tests
2. Toxicology tests
3. Clinical Trial
4. None of the above
5. Clinical trials only |
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Definition
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