Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan

2020 ◽  
Vol 54 (5) ◽  
pp. 1192-1198
Author(s):  
Eiji Kajiwara ◽  
Haruki Kamizato ◽  
Mayumi Shikano
Keyword(s):  
Product Quality ◽  
Quality By Design ◽  
Drug Approval ◽  
Design Development ◽  
New Drug ◽  
Review Period

scholarly journals A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

2017 ◽  
Vol 1 (04) ◽  
pp. 133-146
Author(s):  
Krishna Madagoni ◽  
Uppunuri Saidireddy ◽  
Himaja .
Keyword(s):  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Technical Documentation ◽  
Regulatory Requirements ◽  
Regulatory Decision ◽  
New Drug ◽  
Regulatory Affairs ◽  
Regulatory Approach ◽  
Drug Approval Process

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process and requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.

scholarly journals PENGEMBANGAN LEMBAR KERJA SISWA (LKS) BAHASA INDONESIA KELAS VII DENGAN MODEL PEMBELAJARAN BERBASIS MASALAH

EDU-KATA ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. 145-152
Author(s):  
Sri Rahayu
Keyword(s):  
Data Analysis ◽  
Product Quality ◽  
Development Process ◽  
Problem Based Learning ◽  
Learning Model ◽  
Design Development ◽  
Student Work ◽  
Two Stages ◽  
D Model

The research aimed to (1) describe the process of developing the Indonesian Student Workheet using Problem Based Learning Model, (2) show the quality of the Indonesian Student Work Sheet using Problem Based Learning Model, including: (a) the product quality of the Student Worksheet and (b) the using quality of the Student Worksheet. The type of the research was research and development using 4-D model, those are definition, design, development, and dissemination. The data collection used instrument of validation sheet from the expert, questionnaire sheet, observation sheet. The technique of data analysis divided into three, the technique of data analysis of student worksheet quality and the implementation of student work sheet using Problem Based Learning. The results showed that the development process consisted of two stages: (1) the analysis phase of the writer’s understanding about the Student Worksheet and it’s need, and (2) the design phase which produced the summaries of the materials in each basic competences. The product quality based on the expert gained the score in average of 72.48%, good, the using quality based on the questionnaires to the teacher and observation to the students gained the score in average of 75, 65, good.

scholarly journals Quality by Design Approach for Design, Development and Optimization of Orally Disintegrating Tablets of Montelukast Sodium

2021 ◽  
Vol 11 (3) ◽  
pp. 288-295
Author(s):  
Hasan Pasha Nazeer Ahmed Sholapur ◽  
Fatima Sanjeri Dasankoppa ◽  
Mudlapur Channabasavaraja ◽  
Revati Dharampal Sagare ◽  
Zaheer Abbas ◽  
...  
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Design Development ◽  
Montelukast Sodium ◽  
Orally Disintegrating Tablets ◽  
Quality By Design Approach

Prediction of roller compacted ribbon solid fraction for quality by design development

2011 ◽  
Vol 213 (1-3) ◽  
pp. 1-13 ◽  
Author(s):  
Jon Hilden ◽  
Gretchen Earle ◽  
Eli Lilly
Keyword(s):  
Solid Fraction ◽  
Quality By Design ◽  
Design Development

SELF-EMULSIFYING DRUG DELIVERY SYSTEM CONTAINING ACECLOFENAC: DESIGN & DEVELOPMENT USING QUALITY BY DESIGN (QBD) CONCEPT

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (06) ◽  
pp. 16-26
Author(s):  
V Suthar ◽  
◽  
M Gokel ◽  
S Butani ◽  
A Solanki
Keyword(s):  
Drug Delivery ◽  
Drug Delivery System ◽  
Delivery System ◽  
Dosage Form ◽  
Quality By Design ◽  
Tween 80 ◽  
Current Approach ◽  
In Vitro Dissolution ◽  
Design Development

The aim of the present study was to develop self-emulsifying drug delivery system (SEDDS) of aceclofenac for potential improvement in the in vitro dissolution. The Food and Drug Control Agency (FDCA) has put more stress on the quality, safety and efficacy of the dosage form. The use of design of experiments and quality by Design (QbD) in the development of self emulsifying drug delivery system (SEDDS) containing aceclofenac is demonstrated. The optimum formulation contained Labrafil M 1944 CS, Tween 80 and Transcutol P. The systematic approach enabled us in identifying the design space. The results revealed that while devising the control strategies during manufacturing, more attention should be focused on the ratios of oil to surfactant and surfactant to co-surfactant. The drug was released at a faster rate due to a large surface area. The current approach enabled us to develop a dosage form which is economic, patient-friendly and does not require assistance of a doctor or nurse, especially at remote places at odd hours.

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