An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction

2019 ◽  
Author(s):  
Lawrence J. Lesko ◽  
Lanyan Fang ◽  
Stephan Schmidt ◽  
Mirjam N. Trame
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Quantitative Modeling ◽  
Modeling Approach ◽  
Generic Drug Product

scholarly journals Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)

2018 ◽  
Vol 6 (2) ◽  
pp. 67-71 ◽  
Author(s):  
Ravish Patel ◽  
Amit Patel ◽  
Tejasvini Gohil
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Regulatory System ◽  
Drug Approval ◽  
Oral Dosage ◽  
Market Regulation ◽  
Product Analysis ◽  
Regulatory Requirement ◽  
Generic Drug Product ◽  
Asean Countries

Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.

scholarly journals An overview on comparative study of registration requirements for generics in US, Canada and Europe

2020 ◽  
Vol 1 (4) ◽  
pp. 117-123
Author(s):  
Suryawanshi Meghraj ◽  
Jain minal
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Technical Requirements ◽  
Generic Drug Product ◽  
Similarities And Differences ◽  
Drug Approval Process ◽  
Country Specific

Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market.

Generic Drug Product Development

2007 ◽  
Author(s):  
Isadore Kanfer ◽  
Leon Shargel
Keyword(s):  
Product Development ◽  
Generic Drug ◽  
Drug Product ◽  
Generic Drug Product
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