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Pharmacy

A Textbook of Pharmaceutical Regulatory Science

B.Pharm (Sem. VIII)

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  • ISBN: 9789395596329
  • Published : August 2023
  • Book Language : English
  • Edition : First
  • Format : Paperback
  • Pages : 120
  • Category:
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Rs.155.00

B.Pharm (Sem. VIII)
Pharmacy
A Textbook of Pharmaceutical Regulatory Science

Pharmaceutical Regulatory Science is the science of developing methods to quantitatively and/or qualitatively analyze and understand the causal relations and mechanisms of the substances and the phenomena around us, and measuring their positive and negative effects. Their efficacy and safety are appropriately predicted, evaluated and judged using the methods developed and the results obtained contributing to public health.. Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application).Regulatory science’ refers to the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools. RA is a dynamic, profitable subject that consists of each clinical and prison components of drug development. DRA experts are devoted folks who take satisfaction in their contribution to improving the fitness and pleasant of life of peoples. Regulatory Science as career is broader than registration of merchandise, they advise organizations each strategically and technically at the highest level. Their function begins proper from improvement of a product to creating, advertising and marketing and submit marketing. Regulatory Affairs experts assist the agency avoid issues due to badly saved information, beside the point clinical questioning or many moreThe syllabus cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more

1. Chapter 

New Drug Discovery & Development
1. 1 Introduction
1.2 Definitions
1.3 Stages of Drug Discovery
1.4 Preclinical studies
1.4.1 Types of trials
1.5 Non clinical studies
1.5.1 Objectives
1.5.2 Non-clinical regulatory guidelines
1.6 Clinical Research
1.6.1 Designing clinical trials
1.6.2 Investigational new drug process
1.6.3 FDA-IND review team
1.6.4 Approval
1.7 Innovators
1.8 Generic drugs
1.8.1 Selection of a generic drug product for manufacture
1.8.2 Consideration in the selection of a generic drug product
for manufacture
1.8.3 Generic drug approval process
1.8.4 Hatch Waxman act amendement
1.9 Comparison of Generics VS Innovators

2. Chapter 

Regulatory Approval Process
2.1 Introduction
2.2 Investigational New Drug (IND)
2.2.1 Types of IND
2.2.1.1 Investigator IND
2.2.1.2 Treatment IND
2.2.1.3 Emergency use IND
2.2.2 Categories of IND
2.2.2.1 Commercial IND
2.2.2.2 Research (Non- commercial IND)
2.2.3 Information areas of IND
2.2.3.1 Animal pharmacology and toxicology studies
2.2.3.2 Manufacturing information
2.2.3.3 Clinical protocol and investigator information
2.2.4 Resources for IND Application
2.2.4.1 Pre-IND consultation programme
2.2.4.2 Guidance documents for INDs
2.2.4.3 Laws, Regulations, Policies and Procedures
2.2.4.4 Code of Federal Regulations (CFR)
2.2.4.5 Emergency use of an Investigation Drugs
2.2.5 Format and Content of IND
2.3 New Drug Applications (NDA)
2.3.1 Goals of NDA
2.3.2 Guidance Documents for NDA
2.3.2.1 Guidelines for submitting supporting documents
in drug applications
2.3.2.2 Laws, Regulations, Policies and Procedures
2.3.2.3 Codes of Federal Regulations (CFR)
2.3.2.4 NDA forms and electronic submission
2.3.2.5 Advisory Committee
2.4 Abbreviated New Drug Application (ANDA)
2.4.1 ANDA Regulatory review Process
2.4.1.1 Bioequivalence review process
2.4.1.2 Labelling review process
2.5 Regulatory authorities and agencies
2.5.1 Regulatory authority of India
2.5.2 Regulatory authority of USA
2.5.3 Regulatory authority of Europe
2.5.4 Regulatory authority of Australia
2.5.5 Regulatory authority of Japan
2.5.6 Regulatory authority of Canada

3. Chapter 

Registration of Indian Drug Products in Market
3.1 Introduction
3.2 Procedure For Export of Pharmaceutical Products and medicines from India
3.2.1 Getting import export code
3.2.2 Documents to be uploaded
3.2.3 Custom clearance
3.3 Drug Master File
3.3.1 Types of Drug Master File
3.3.2 Submission of Drug Master File
3.3.3 Administrative Information
3.4 Common Technical Document & eCTD
3.4.1 Modules of CTD
3.4.2 eCTD

4. Chapter 

Clinical Trials
4.1 Introduction
4.1.1 Phases of clinical trials
4.2 Protocol
4.2.1 Aims of the protocol
4.2.2 Benefits of the protocol
4.2.3 Protocol Review
4.2.4 Writing the protocol
4.3 Institute Review Board/Independent Ethics Committee (IRB/IEC)
4.3.1 IRB Responsibilities
4.3.2 Composition, Functions and Operations of IRB
4.3.3 Procedure
4.4 Records
4.5 GCP (Good Clinical Practices)
4.5.1 Principles of GLP
4.5.2 Investigator
4.6 Medical Care of Trial Subjects
4.6.1 Compliance with Protocol
4.6.2 Investigational Products
4.6.3 Randomization Procedures and Unbinding
4.7 Informed Consent of Trial Subjects
4.8 Records and reports
4.9 Quality management
4.10 Quality assurance and quality control
4.11 Contract Research Organization (CRO)
4.12 Management, Data Handling, and Record Keeping
4.13 Monitoring Procedure
4.14 Pharmacovigilance
4.14.1 Introduction
4.14.2 Aim
4.14.3 ADRS

5. Chapter 

Regulatory Concepts
5.1 Regulatory Concepts
5.2 Basic Terminology
5.3 Guidelines & Regulations
5.4 Orange Book
5.5 Federal Register
5.6 Code of Federal Regulatory
5.7 The Purple Book

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