11.1 Overview of Biotechnology in Pharmaceuticals
714. Preclinical Studies:
21.2 Historical Perspectives
725. Clinical Trials:: •Success Stories and Case Studies:
31.3 Current Trends and Future Prospects: Introduction
731. Hydroxychloroquine:
41.4 Regulatory Framework: Introduction to Pharmaceutical Biotechnology: Regulatory Framework
742. Thalidomide:
51.5 Ethical Considerations
753. Ketamine:
61.6 Industrial Applications
76•Challenges and Opportunities:
7Introduction to Pharmaceutical Biotechnology: Industrial Applications: Introduction to Pharmaceutical Biotechnology: Industrial Applications in Pharmaceuticals
77•Challenges:
81.7 Challenges and Opportunities
781. Intellectual Property Issues:
91.8 Key Terminologies
792. Regulatory Complexities:
101. Biopharmaceuticals:
803. Market Competition:
112. Recombinant DNA Technology:
814. Financial Incentives:: •Opportunities:
123. Monoclonal Antibodies:
821. Collaborative Partnerships:
134. Gene Therapy:
832. Regulatory Support:
145. Pharmacogenomics:
843. Market Access Strategies:
152.1 DNA Structure and Function
854. Therapeutic Innovation:
162.2 RNA Structure and Function
866.1 Principles of Drug Delivery
172.3 Protein Synthesis
876.2 Oral Drug Delivery Systems
182.4 Gene Expression Regulation
886.3 Injectable Drug Delivery Systems
192.5 Recombinant DNA Technology
896.4 Topical and Transdermal Delivery Systems
202.6 Cloning Techniques
90•Introduction to Drug Delivery Systems
212.7 Genetic Engineering Tools
91•Topical Drug Delivery Systems
222.8 Genomics and Proteomics
92•Transdermal Drug Delivery Systems
23•Genomics:
93•Applications of Topical and Transdermal Delivery Systems
24•Proteomics:: •Integration of Genomics and Proteomics in Pharmaceuticals:
94•Conclusion
253.1 Cell Culture Basics
956.5 Pulmonary Drug Delivery Systems
263.2 Types of Cell Cultures
96•Introduction:
27• Monolayer Cell Culture:
97•Mechanism of Action:
28•Suspension Cell Culture:
98•Formulation Considerations:
29• 3D Cell Culture:
99•Applications in Pharmaceuticals:
30•Organotypic Cell Culture:: •Co-culture Systems:
100•Advancements and Future Directions:
313.3 Primary Cell Culture Techniques
1016.6 Nasal Drug Delivery Systems
32•Principles of Primary Cell Culture:
1026.7 Ocular Drug Delivery Systems
33•Methodologies of Primary Cell Culture:: •Applications of Primary Cell Culture in Pharmaceuticals:
103•Introduction to Ocular Drug Delivery Systems
343.4 Cell Line Development
104•Types of Ocular Drug Delivery System
353.5 Culture Media and Supplements
105•Challenges and Future Direction: •Future Directions:
363.6 Cell Culture Scale-Up
1066.8 Controlled Release Systems
373.7 Quality Control in Cell Culture
1076.1 Principles of Drug Delivery
383.8 Advanced Cell Culture Systems
1087.1 Absorption, Distribution, Metabolism, and Excretion (ADME)
394.1 Definition and Classification of Biopharmaceuticals
109•Absorption:
404.2 Monoclonal Antibodies
110•Distribution:
414.3 Recombinant Proteins
111•Metabolism:
424.4 Vaccines
112Excretion:
434.5 Gene Therapy Products
1137.2 Pharmacokinetic Parameters
444.6 Biosimilars
1147.3 Pharmacodynamic Principles
454.7 Production Platforms
1157.4 Mechanisms of Drug Action
464.8 Downstream Processing: 5.1 Target Identification and Validation
1167.5 Immunogenicity and Tolerance
475.2 High-Throughput Screening
1177.6 Drug Interactions
485.3 Rational Drug Design
1187.7 Therapeutic Drug Monitoring: 7.8 Personalized Medicine Approaches
491. Precision Medicine Advancements:
1198.1 Preclinical Studies
502. Overcoming Drug Resistance:
1208.2 Clinical Trial Phases
513. Multi-Target Drug Design:
1218.3 Regulatory Submission Process: 8.4 Good Clinical Practice (GCP) Guidelines
524. Integration of Big Data and Artificial Intelligence:
1228.5 Post-Marketing Surveillance
535. Natural Products as Drug Leads:
1238.6 Drug Approval Pathways
546. Regulatory Considerations and Intellectual Property:
1248.7 Patent and Intellectual Property Issues
55•Regulatory Oversight
1258.8 International Harmonization Efforts
56•Clinical Trials
1269.1 Toxicology Studies
57•Quality Control
1279.2 Safety Pharmacology
58•Intellectual Property Protection
1289.3 Immunogenicity Assessment
59•Regulatory Pathways
1299.4 Adverse Event Reporting
605.4 Structure-Activity Relationship (SAR) Studies
1309.5 Risk Management Plans
615.5 Computer-Aided Drug Design (CADD)
1319.6 Signal Detection and Management
625.6 Fragment-Based Drug Design
1329.7 Post-Marketing Safety Surveillance
635.7 Pharmacogenomics
1339.8 Pharmacovigilance Systems and Regulations
645.8 Drug Repurposing
13410.1 Next-Generation Biopharmaceuticals
65•Introduction to Drug Repurposing:
13510.2 Advanced Drug Delivery Systems
66•Rationale for Drug Repurposing:
13610.3 Personalized Medicine Advances
67•Methods and Approaches:
13710.4 CRISPR/Cas9 and Genome Editing
681. Computational Techniques:
13810.5 Nanotechnology in Pharmaceuticals
692. High-Throughput Screening Assays:
13910.7 Stem Cell Therapies: 10.8 Regulatory Challenges and Adaptations
703. In Silico Modeling:
