Clinical Drug Development and Industrial Pharmacy
  by Arun Radhakrishnan & Karri V V S Narayana Reddy
 
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   ISBN 978-93-85529-??-?; 1st Ed. 2020; pp.vii+???

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 About The Book  

  Industrial pharmacy is a discipline overseeing the phases of product development from manufacture to marketing and distribution of drugs while ensuring a quality check of these activities. Perfect clinical trial with authentic regulatory submission is very much important to carry execute successful drug development process.

  This book informs the basic knowledge of Industrial Pharmacy and clinical trails along with regulations keeping abreast the Final Year B. Pharmacy (Semester-VII) syllabus Industrial Pharmacy II designed by Pharmacy Council of India, New Delhi as per the revised regulations for the Bachelor of Pharmacy degree program Course regulations 2014.

  Special interest has been taken in adhering to the topics such as the process of pilot plant and scale up of pharmaceutical dosage forms, technology transfer from lab scale to commercial batch, quality management systems, clinical trials and regulatory requirements for drug approval. A theoretical knowledge on these can be quite useful for pursuing a career as an industrial pharmacist or in regulatory department.

  The content is written in a simple manner with revision questions at end of each chapter making it student-friendly.

 Content


1 PILOT PLANT SCALE UP TECHNIQUES
    Introduction
    Objectives
    Components
    Pilot plant scaleup consideration for solid orals
    Pilot plant Scaleup consideration for liquids
    Pilot plant Scaleup consideration for semisolids
    Documentation
    SUPAC
    Platform technology

2 TECHNOLOGY DEVELOPMENT AND TRANSFER
    Introduction
    Objectives
    Protocol
    R & D to production transfer
    Analytical technology transfer
    Qualification and Validation
    Documentation
    Quality risk management
    Regulatory bodies and agencies
    WHO Guidelines

3 QUALITY MANAGEMENT SYSTEMS
    Concept of Quality
    Total Quality Management
    Quality by Design (QbD)
    Six Sigma concept
    Out of Specifications (OOS)
    Change control
    Introduction to ISO 9000 series of quality systems standards, ISO 14000
    NABL
    GLP

 
4 REGULATORY AFFAIRS
    Introduction
    History of Pharmaceutical Regulatory Affairs
    Pharmaceutical Regulatory agencies
    Roles and responsibilities

5 REGULATORY REQUIREMENTS FOR DRUG APPROVAL
    Drug development process
    Drug development teams
    Clinical trial protocol
    Clinical trial data collection and management
    Bioavailability and Bioequivalence studies
    Biostatistics in pharmaceutical product development

6 INDIAN REGULATORY REQUIREMENTS
    Central Drug Standard Control Organization (CDSCO)
    Regulatory requirements and approval procedures for New Drugs
    Certificate of Pharmaceutical Product (COPP)


APPENDICES