INFLUENCE OF (QbR) QUESTION BASED REVIEW TO REVAMP CMC SUBMISSION REVIEW
Journal Title: World Journal of Pharmaceutical and Medical Research - Year 2018, Vol 4, Issue 4
Abstract
QbR for CMC evaluation of an ANDA is focused on critical pharmaceutical attributes. When an applicant submits a QOS of CMC that fully addresses the QbR, this helps to assure product quality and may reduce the number of CMC review cycles by enhancing the quality of submissions and reviews through the use of a standardized set of critical questions. Question-based review (QbR) is a science and risk-based approach to the Chemistry, Manufacturing, and Controls (CMC) evaluation of an Abbreviated New Drug Application (ANDA) to ensure pro duct quality. The QbR questions and this guidance document, in order to adequately assess the safety, effectiveness, and quality of the product. This new QbR system incorporates quality by design and implements risk-based assessment. It recommends that ANDAs be submitted using the Common Technical Document and include the Quality Overall Summary (QOS) that addresses all the QbR questions. This retrospective study explains about the CMC and its challenges and importance of QbR and how QbR will transform the CMC review.
Authors and Affiliations
Dr. Balasubramanian J.
Keywords
Related Articles
- EP ID EP660547
- DOI -
- Views 157
- Downloads 0
AN ANEMIC NATION: A FOCUS ON THE PREVALENCE OF ANEMIA
Objective: To assess the frequency of anemia in adults of Pakistan. Introduction; Anemia is a still widely prevalent among the apparently healthy adults of Pakistan. This study is to assess the frequency of anemia in adu...
CLINICAL STUDY OF PRATIVISHADI TAIL KARANPURNA AND ASHWAGANDHADYA GHRITA PAANA IN THE MANAGEMENT OF KARAN NAAD W.S.R. TO TINNITUS
Aacharya Sushruta has explained about Karna-Nada & Karna Kshweda. Vitiated Vata Dosha either entering into other channels or encircled by Kaphadi Doshas) in Sabdavaha Srotas produces different types of sounds in the ear...
IS ATTENTION DEFICIT /HYPERACTIVITY DISORDER (ADHD) A DIAGNOSIS OR A SYMPTOM COMPLEX? EXPERIENCE FROM PEDIATRIC ORTHOPEDIC PRACTICE
Objective: Attention deficit hyperactivity disorder (ADHD) is a group of behavioral symptoms that include hyperactivity and impulsiveness. The etiological understanding is somehow controversial. We aimed to study the eti...
THE LONG-TERM OUTCOME OF CYCLOPHOSPHAMIDE ORAL VERSUS INTRAVENOUS IN CHINESES CHILDREN WITH STEROID DEPENDENT NEPHROTIC SYNDROME
Objectives: To investigate the effects of oral or intravenous cyclophosphamide with steroid dependent nephrotic syndrome(SDNS) children. Method: Sixty-nine SDNS children(39 girls and 30 boys) aged 1 to 14 years were trea...
RENAL CALCULUS - A REVIEW ARTICLE
Lactic acid bacteria, Lactobacillus plantarum and Lactobacillus pentosus, were isolated from the breast milk of six healthy breast feeding mothers using MRS agar media and API50CHL kit and the total Lactic Acid Bacteria...