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About The Book
This book meets the uniform syllabus prescribed by the Pharmacy Council of India (Vide no. Gazette of India, No. 362, dt. December, 2014) of Master of Pharmacy (Pharmaceutics) course regulations. It will also be of use to the research scholars at PG and Ph.D. levels. These enrich the concepts and value-added knowledge base of persons working in the industry and research organizations. Due to availability of user friendly software, the application of principles into practice is possible irrespective of the level of computer literacy of reader.
This book begins with an appreciation and understanding of computers, hardware, software and special computational methods for drug discovery and development. Several techniques of formulation development are explained with the inputs of computers. A recent topic namely artificial intelligence is included with its applications in the formulation development, robotics, automation and artificial neural networks. The topic of QbD has been widely discussed from the regulatory perspectives. This book takes care of additional details of elements, functions, tools and related principles, which may initiate updating the syllabus.
The 18 chapters cover areas, such as Computers in Pharmaceutical Research and Development; Statistical and Modeling Simulations; Tumor Growth, Gompertz Model–Statistical Simulations; Quality by Design in Pharmaceutical Development; Experimental Designs in Formulation Development; Computer Aided Formulation Development–Complex Systems; Computational Fluid Dynamics in Pharmaceutical Development; Artificial Intelligence (AI); Expert and Knowledge Based Systems; Artificial Neural Networks (ANN); Computational Methods in Pharmacokinetics; Computer-aided Biopharmaceutical Characterization; Computer Simulations in Pharmacokinetics and Pharmacodynamics; Computers in Clinical Development-Data Collection and Data Management; Ethics of Computing in Pharmaceutical Research; Computer Market for Pharmaceutical Research; Regulations of Computer Systems and Legal Protection of Innovative Computer Related Systems.
Special emphasis is given to the requirements and expectations of the reader.
1. Application of principles
2. A number of illustrations on the lines of concept mapping
3. Question bank for drawing the attention of relevant particulars.
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Chapter 1. COMPUTER TECHNOLOGIES IN PHARMACEUTICAL RESEARCH
Computational Techniques – Advances in Hardware
Computational Techniques – Advances in Software
Special Tools for Drug Discovery
Computational Techniques – Product Development
Question Bank
Chapter 2. STATISTICAL MODELING AND SIMULATIONS – PRINCIPLES
Parametric Versus Nonparametric Models
Descriptive Versus Mechanistic Models
Computer Simulations
Simulation – Components and Construction
Question Bank
Chapter 3. TUMOR GROWTH, GOMPERTZ MODEL – STATISTICAL MODELING
Functional Form of Model – Tumor Growth
Statistical Parameters – Estimations
Tumor Growth – Confidence Regions
Tumor Growth – Sensitivity Analysis
Tumor Growth – Sample Times - D-Optimal Design
Tumor Growth – Population Modeling
Question Bank
Chapter 4. QBD IN PHARMACEUTICAL DEVELOPMENT
Regulatory View of QbD
Elements of QbD
Question Bank
Chapter 5. EXPERIMENTAL DESIGNS IN FORMULATION DEVELOPMENT
Mathematical Models and Statistical Tests
Search Methods and Simulations
Screening Designs
Factorial Designs
Response Surface Designs
Simplex Designs
Mixture Designs
Question Bank
Chapter 6. COMPUTER IN FORMULATION DEVELOPMENT - COMPLEX SYSTEMS
Formulation of Emulsions –Computer Techniques
Formulation of Multiple Emulsions –Computer Techniques
Formulation of Microemulsion and Carriers Systems –Computer Techniques
Question Bank
Chapter 7. COMPUTATIONAL FLUID DYNAMICS
– APPLICATIONS IN PHARMCEUTICAL TECHNOLOGY
Theoretical Principles-CFD
Methods of Measuring CFD
Fluidized Bed Processor – CFD Simulations
Drug Dissolution Testing - Hydrodynamics
Dry Powder Inhalers - Computational Fluid Dynamics
Question Bank
Chapter 8. ARTIFICIAL INTELLIGENCE – TECHNOLOGIES AND APPLICATIONS
Artificial Intelligence - Technologies
Applications of Artificial Intelligence
Artificial Intelligence and Robotics
Robots and Pharmaceutical Applications
AI - Robots - Automation
Components of Automation
Automation -Applications
Question Bank
Chapter 9. EXPERT AND KNOWLEDGE BASED SYSTEMS
– FORMULATION DEVELOPMENT
Elements of Expert System
Expert Systems – Formulation Development
Artificial Intelligence – Expert Systems
Expert System Simulations – Formulation Development
Question Bank
Chapter 10. ARTIFICIAL NEURAL NETWORKS - PRINCIPLES
Buildup of Artificial Neural Network - Model
Working of the Artificial Neural Network
Training and Testing of the Artificial Neural Network
Static Neural Networks
Dynamic Neural Networks
Fuzzy Logic
Evolutionary Computing and Genetic Algorithm
Self-organizing Maps
Question Bank
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Chapter 11. COMPUTATIONAL MODELING AND PHARMACOKINETICS OF DRUGS
Drug Distribution-Principles
Drug Distribution-Computational Models
Biotransformation-Principles
Biotransformation-Computational Models
Renal Excretion of Drugs-Principles
Renal Excretion of Drugs-Computational Models
Drug Absorption-Principles
Drug Absorption-Computational Models
Computational Approaches
Question Bank
Chapter 12. COMPUTERS AIDED BIOPHARMACEUTICAL CHARACTERIZATION
ACAT Model - Construction
ACAT Modeling and GI Simulations
Model Exploration
Parameter Sensitivity Analysis
Virtual Trials
Fed and Fasted States – GIST Analysis
In Vitro Dissolution – In vitro-In vivo Correlations
Biowaiver Considerations as per BCS – Drug Approval
Question Bank
Chapter 13. COMPUTER SIMULATIONS FOR PK AND PD
Simulation – Software
Pharmacokinetic Modeling
Pharmacodynamics Modeling
Computer Simulations of Whole Organism
Computer Simulations of Isolated Tissue/Organs
Computer Simulations of the Cell
Computer Simulations of Proteins and Genes
Question Bank
14. COMPUTERS IN CLINICAL DATA COLLECTION AND MANAGEMENT
Data Collection - Elements
Data Collection – Tools and Procedures
Clinical Research -Software and Hardware
Clinical Data Management System
Communication-Tools
Question Bank
15. COMPUTER ETHICS - COMPUTING IN PHARMACEUTICAL RESEARCH
Historical Perspectives of Computer Ethics
Code of Conduct- Use of Computers
Computer Ethics-Issues and Conflicts
Computational Techniques – Issues of Ethics
Question Bank
16. MARKET OF COMPUTERS – FEATURES OF MOTIVATION
Clinical Research and Efficiency
Data Analysis – Software Support
Computers - Decision Making
Question Bank
17. COMPUTER SYSTEMS – ELECTRONIC REGULATIONS
Electronic Records
Electronic Signatures
Question Bank
18. COMPUTER RELATED INVENTIONS - IPRS
Computer-Related Inventions
Computer Related Inventions - Patents
Computer Related Inventions - Copyrights
Computer Related Inventions – Trade Secrets
Question Bank
APPENDIX-I : Definitions and Meanings
APPENDIX-II : All In Twos—Know Them Well
Appendix-III : Bibliography
Appendix-IV : Abbreviations
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