| 000 -LEADER |
|---|
| fixed length control field |
a |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20191018143230.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
191018b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
AIKTC-KRRC |
| Transcribing agency |
AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
|---|
| 9 (RLIN) |
9941 |
| Author |
Akshatha G. |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Chemistry, Manufacturing and Control (CMC) Evaluations of ANDA Submission in the USA |
| 250 ## - EDITION STATEMENT |
|---|
| Volume, Issue number |
Vol.53(3), Jul-Sep |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
Karnataka |
| Name of publisher, distributor, etc. |
Indian journal of pharmaceutical education and research |
| Year |
2019 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Pagination |
514-420p. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
Background: The Abbreviated New Drug Application commonly referred as ANDA is an application that contains data submitted to US FDA for the review and prospective marketing authorization of generic drugs. The conduct of the reviewing of the application is done by the Division of Filing Review (DFR), Office of Regulatory Operations (ORO) in the Office of Generic Drugs (OGD). The format of ANDA: USFDA recommends the submission of ANDA applications as per ICH Common Technical Document (CTD) format. Module 3: Module 3 of CTD contains Chemistry, Manufacturing and Control (CMC) information including all the supporting details verifying that was summarised in section 2.3 which is the quality overall summary. Evaluation of ANDA: For the evaluation of an Abbreviated New Drug Application in the US, its Office of Generic Drugs (OGD) has developed a Question-based Review (QbR) for its CMC section which is mainly focussed on the critical quality attributes. Conclusion: The implementation of Question-based Review programme is yielding good improvements in FDA’s division of Office of Generic Drugs (OGD), i.e., by advancing the review pattern of the ANDA CMC section without compromising quality and efficacy for the indication of the generic product. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| 9 (RLIN) |
4639 |
| Topical term or geographic name entry element |
PHARMACEUTICS |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| 9 (RLIN) |
8811 |
| Co-Author |
Anoop Narayanan V. |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Indian journal of pharmaceutical education and research |
| International Standard Serial Number |
0019-5464 |
| Place, publisher, and date of publication |
Bengluru Association of Pharmaceutical Teachers of India (APTI) |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| URL |
https://www.ijper.org/sites/default/files/IndJPhaEdRes_53_3_414-420.pdf |
| Link text |
Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Koha item type |
Articles Abstract Database |
