Pharmaceutical Biotechnology Fundamentals and Applications - Lecture Notes, Study Material and Important Questions, Answers

Pharmaceutical Biotechnology: Fundamentals and Applications
Subject : Pharmaceutical Biotechnology: Fundamentals and

Applications
Molecular Biotechnology
1. Molecular Biotechnology: Introduction - Answer (click here)
2. The Cells: Prokaryotic Cell and Eukaryotic Cell - Answer (click here)
3. Gene Expression - Answer (click here)
4. DNA Replication - Answer (click here)
5. Gene Transcription - Answer (click here)
6. Gene Translation - Answer (click here)
7. Recombinant DNA Technology - Answer (click here)
8. DNA Transfer - Recombinant DNA Technology - Answer (click here)
9. DNA Sources - Recombinant DNA Technology - Answer (click here)
10. Production by Recombinant DNA Technology - Answer (click here)
11. DNA Sequencing - Answer (click here)
12. Genome Sequencing - Answer (click here)
13. DNA Hybridization - Answer (click here)
14. PCR Technology - Answer (click here)
15. Cell Cultures: Cultivation of Microbes, Animal and Plant Cell Cultures -
Answer (click here)
Biophysical and Biochemical Analysis of Recombinant Proteins

Answer (click here)
16. Biophysical and Biochemical Analysis of Recombinant Proteins - Answer
(click here)
17. Protein Structure: Primary Structure - Answer (click here)
18. Protein Structure: Secondary Structure - Answer (click here)
19. Protein Structure: Tertiary Structure - Answer (click here)
20. Protein Structure: Forces - Answer (click here)
21. Protein Structure: Hydration - Answer (click here)
22. Protein Folding - Answer (click here)
23. Protein Stability - Answer (click here)
24. Blotting Techniques - Proteins Analytical Techniques - Answer (click here)
25. Immunoassays ELISA - Proteins Analytical Techniques - Answer (click
here)
26. Electrophoresis - Proteins Analytical Techniques - Answer (click here)
27. Chromatography - Proteins Analytical Techniques - Answer (click here)
28. Bioassays - Proteins Analytical Techniques - Answer (click here)
29. Mass Spectrometry - Proteins Analytical Techniques - Answer (click here)
Production and Downstream Processing of Biotech Compounds

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30. Production and Downstream Processing of Biotech Compounds - Answer
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31. Expression Systems - Production of Biotech Compounds - Answer (click
here)
32. Cultivation Systems - Production of Biotech Compounds - Answer (click
here)
33. Cultivation Medium - Production of Biotech Compounds - Answer (click
here)
34. Contaminants - Production of Biotech Compounds - Answer (click here)
35. Cellular DNA - Production of Biotech Compounds - Answer (click here)
36. Downstream Processing of Biotech Compounds - Answer (click here)
37. Filtration/Centrifugation - Downstream Processing of Biotech
Compounds - Answer (click here)
38. Precipitation - Downstream Processing of Biotech Compounds - Answer
(click here)
39. Chromatography - Downstream Processing of Biotech Compounds -
Answer (click here)
40. Issues to Consider in Production And purification of Proteins - Answer
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Formulation of Biotech Products Including Biopharmaceutical

Considerations
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41. Microbiological Considerations - Answer (click here)
42. Excipients Used in Parenteral Formulations of biotech Products - Answer
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43. Solubility Enhancers - Excipients Used in Parenteral Formulations of
biotech Products - Answer (click here)
44. Anti Adsorption and Anti Aggregation Agents - Excipients Used in
Parenteral Formulations of biotech Products - Answer (click here)
45. Buffer Components - Excipients Used in Parenteral Formulations of
46. Preservatives and Antioxidants - Excipients Used in Parenteral
Formulations of biotech Products - Answer (click here)
47. Osmotic Agents - Excipients Used in Parenteral Formulations of biotech
Products - Answer (click here)
48. Shelf Life of Protein Based Pharmaceuticals - Excipients Used in
49. Freeze Drying of Proteins - Excipients Used in Parenteral Formulations
of biotech Products - Answer (click here)
50. Freezing - Excipients Used in Parenteral Formulations of biotech
51. Primary Drying - Excipients Used in Parenteral Formulations of biotech
52. Secondary Drying - Excipients Used in Parenteral Formulations of
53. Delivery of Proteins: Routes of Administration and Absorption
Enhancement - Answer (click here)
54. Delivery of Proteins: By The Parenteral Route - Answer (click here)
55. Delivery of Proteins: Approaches For Rate Controlled Delivery - Answer
(click here)
56. Delivery of Proteins: Site Specific Delivery (Targeting) of Protein Drugs
- Answer (click here)
57. Anatomical, Physiological, and Pathological Considerations Relevant for
Protein Targeting - Answer (click here)
58. Soluble Carrier Systems for Targeted Delivery of Proteins - Answer (click
here)
59. Potential Pitfalls in Tumor Targeting - Answer (click here)
60. Colloidal Particulate Carrier Systems for TargetedDelivery of Proteins:
Nanotechnology at Work - Answer (click here)
61. Perspectives for Targeted Protein Delivery - Answer (click here)
Pharmacokinetics and Pharmacodynamics of Peptide and Protein

Drugs
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62. Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs -
Answer (click here)
63. Pharmacokinetics of Protein Therapeutics - Answer (click here)
64. Absorption of Protein Therapeutics - Pharmacokinetics of Protein
Therapeutics - Answer (click here)
65. Distribution of Protein Therapeutics - Pharmacokinetics of Protein
66. Elimination of Protein Therapeutics - Pharmacokinetics of Protein
67. Target Mediated Drug Disposition - Pharmacokinetics of Protein
68. Immunogenicity and Protein Pharmacokinetics - Pharmacokinetics of
Protein Therapeutics - Answer (click here)
69. Species Specificity and Allometric Scaling - Pharmacokinetics of
70. Chemical Modifications for Optimizing the Pharmacokinetics of Protein
Therapeutics - Pharmacokinetics of Protein Therapeutics - Answer (click
here)
71. Pharmacodynamics of Protein Therapeutics - Answer (click here)
72. Direct Link PK/PD Models - Pharmacodynamics of Protein Therapeutics
73. Indirect Link PK/PD Models - Pharmacodynamics of Protein
74. Indirect Response PK/PD Models - Pharmacodynamics of Protein
75. Cell Life Span Models - Pharmacodynamics of Protein Therapeutics -
Answer (click here)
76. Complex Response Models - Pharmacodynamics of Protein
Immunogenicity of Therapeutic Proteins

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77. Immunogenicity of Therapeutic Proteins - Answer (click here)
78. The New Paradigm - Answer (click here)
79. The Immunological Response - Answer (click here)
80. Factors Influencing Antibody Formation Totherapeutic Proteins - Answer
(click here)
81. Assays for Antibodies - Answer (click here)
82. Issues Specifically Related Tomonoclonal Antibodies - Answer (click here)
83. Clinical Effects of Induced Antibodies - Answer (click here)
84. Predicting and Reducing Immunogenicity - Answer (click here)
Genomics Other Omics Technologies Personalized Medicine and

Additional Biotechnology Related Techniques
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85. Genomics, “Omics” Technologies, Personalized Medicine - Answer (click
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86. An Introduction to “Omics” Technologies - Answer (click here)
87. Genomics - An Introduction to “Omics” Technologies - Answer (click here)
88. “Omics” Enabling Technology: Bioinformatics - Answer (click here)
89. Transcriptomics - An Introduction to “Omics” Technologies - Answer
(click here)
90. Proteomics, Structural Proteomics, and Functional Proteomics - “Omics”
Technologies - Answer (click here)
91. “Omics” Enabling Technology: Microarrays - Answer (click here)
92. “Omics” Enabled Technology: BriefIntroduction to Biomarkers - Answer
(click here)
93. Metabonomics and Metabolomics - Answer (click here)
94. Pharmacogenetics and Pharmacogenomics - Answer (click here)
95. Toxicogenomics - Answer (click here)
96. Glycomics and Glycobiology - Answer (click here)
97. “Omics” Integrating Technology: Systems Biology - Answer (click here)
98. Transgenic Animals - Answer (click here)
99. Transgenic Plants - Answer (click here)
100. Xenotransplantation: Transplantable Transgenic Animal Organs - Answer
(click here)
101. Knockout Mice - Answer (click here)
102. Protein Engineering - Answer (click here)
103. 3D Structures of Engineered Proteins - Answer (click here)
104. Peptide Chemistry and Peptidomimetics - Answer (click here)
105. Cell Therapy and Regenerative Medicine - Answer (click here)
106. Stem Cells - Cell Therapy and Regenerative Medicine - Answer (click here)
107. Tissue Engineering and Some Products of Tissue Engineering - Cell
Therapy and Regenerative Medicine - Answer (click here)
108. Biotechnology and Drug Discovery - Answer (click here)
109. Screening and Synthesis - Biotechnology and Drug Discovery - Answer
(click here)
110. Chemical Genomics - Biotechnology and Drug Discovery - Answer (click
here)
Gene Therapy
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111. Gene Therapy - Answer (click here)
112. Ex Vivo Versus In Vivo Gene Therapy - Answer (click here)
113. Gene Therapy in The Clinic: Disease Targets - Answer (click here)
114. General Considerations - Vectors For Gene Transfer - Answer (click here)
115. General Anatomy and Production of a Gene Transfer Vector - Answer
(click here)
116. Retroviral Vectors - Viral Vectors for Gene Transfer - Answer (click here)
117. Adenoviral Vectors - Viral Vectors for Gene Transfer - Answer (click here)
118. Adeno Associated Virus Vectors - Viral Vectors for Gene Transfer -
Answer (click here)
119. Non-Viral Vectors for Gene Transfer - Answer (click here)
120. Construction of Non Viral Vectors - Answer (click here)
121. Delivery Methods for Non-Viral Gene Transfer - Answer (click here)
122. The Immune Response Against Non-Viral Vectors - Answer (click here)
123. Clinical Use of Non-Viral Vectors - Answer (click here)
124. Production and Processing of Non-Viral Vectors - Answer (click here)
125. The Role of Drug Metabolism in Gene Therapy - Answer (click here)
126. Gene Directed Enzyme Prodrug Therapy (GDEPT) - Answer (click here)
127. Systems for Pharmacological Regulation of Gene Expression - Answer
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128. Regulation and Oversight of Gene Therapy Products - Answer (click here)
Oligonucleotides
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129. Oligonucleotides - Answer (click here)
130. Interfering With Gene Expression - Oligonucleotides - Answer (click here)
131. Triple Helix-Forming Oligonucleotides - Answer (click here)
132. Transcription Factor Decoys - Oligonucleotides Interfering With Gene
Expression - Answer (click here)
133. Antisense/Ribozymes/EGS - Oligonucleotides Interfering With Gene
134. siRNA/miRNA - Oligonucleotides Interfering With Gene Expression -
Answer (click here)
135. Direct Binding to Non-Nucleic Acids - Answer (click here)
136. Gene Repair - Answer (click here)
137. Stimulating Immune Responses - Answer (click here)
138. Pharmacokinetics of Oligonucleotide-Based Therapeutics - Answer (click
here)
139. Improving Oligonucleotide Stability - Answer (click here)
140. Improving Cellular Uptake - Answer (click here)
141. Diagnostic Applications - Answer (click here)
Hematopoietic Growth Factors

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142. Hematopoietic Growth Factors - Answer (click here)
143. Hematopoiesis - Answer (click here)
144. Chemical Description of Hematopoietic Growth Factors - Answer (click
here)
145. Chemical Properties and Marketing Information for the Myeloid Factors,
G-CSF and GM-CSF - Answer (click here)
146. Chemical Properties and Marketing Information for SCF - Answer (click
here)
147. Chemical Properties and Marketing Information for TPOs - Answer (click
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148. Pharmacology - Answer (click here)
149. Pharmaceutical Issues - Answer (click here)
150. Pharmacokinetics - Answer (click here)
151. Pharmacodynamics - Answer (click here)
152. Established Uses - Hematopoietic Growth Factors - Answer (click here)
153. AIDS - Pharmaceutical Biotechnology - Answer (click here)
154. Toxicities - Answer (click here)
Interferons and Interleukins

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155. Interferons and Interleukins - Answer (click here)
156. Interferons: Nomenclature and Functions - Answer (click here)
157. Interleukins: Nomenclature and Functions - Answer (click here)
158. Rapeutic Use of Recombinant Interferons - Answer (click here)
159. Therapeutic Use of Recombinant Interleukins - Answer (click here)
160. Aldesleukin - Therapeutic Use of Recombinant Interleukins - Answer
(click here)
161. Oprelvekin - Therapeutic Use of Recombinant Interleukins - Answer (click
here)
162. Anakinra - Therapeutic Use of Recombinant Interleukins - Answer (click
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163. Pegylated Interferons and Interleukins: The Next Generation - Answer
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Insulin
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164. Insulin - Answer (click here)
165. Chemical Description of Insulin - Answer (click here)
166. Pharmacology and Formulations of Insulin - Answer (click here)
167. Regular and Rapid Acting Soluble Formulations - Pharmacology and
Formulations of Insulin - Answer (click here)
168. Intermediate Acting Insulin Formulations - Pharmacology and
169. Long Acting Insulin Formulations - Pharmacology and Formulations of
Insulin - Answer (click here)
170. Chemical Stability of Insulin Formulations - Answer (click here)
171. Physical Stability of Insulin Formulations - Answer (click here)
172. Clinical and Practice Aspects of Insulin - Answer (click here)
Growth Hormones
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173. Human growth hormone (hGH): Structure and Isohormones - Answer
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174. Growth Hormone Secretion and Regulation - Answer (click here)
175. Growth Hormone Biologic Actions - Answer (click here)
176. hGH Receptor and Binding Proteins - Answer (click here)
177. Molecular Endocrinology and Signal Transduction - Answer (click here)
178. Dosing Schedules and Routes of Human growth hormone (hGH) -
Answer (click here)
179. Pharmacokinetics and Metabolism - Answer (click here)
180. Protein Manufacture, Formulation and Stability- Growth Hormones -
Answer (click here)
181. Clinical Usage of Human growth hormone (hGH) - Answer (click here)
Recombinant Coagulation Factors and Thrombolytic Agents

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182. Recombinant Coagulation Factors and Thrombolytic Agents - Answer
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183. Recombinant Coagulation Factors VIII - Answer (click here)
184. Recombinant Coagulation Factor VIIA - Answer (click here)
185. Recombinant Coagulation Factor IX - Answer (click here)
186. Tissue Type Plasminogen Activator - Recombinant Thrombolytic
Agents - Answer (click here)
187. Recombinant t-PA (rt-PA; Alteplase) - First Generation Recombinant
Thrombolytic Agents - Answer (click here)
188. Second Generation Recombinant Thrombolytic Agents - Answer (click
here)
189. Reteplase - Second Generation Recombinant Thrombolytic Agents -
Answer (click here)
190. Tenecteplase - Thrombolytic Agents - Answer (click here)
191. Lanoteplase - Thrombolytic Agents - Answer (click here)
Monoclonal Antibodies From Structure to Therapeutic

Application
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192. Monoclonal Antibodies: From Structure to Therapeutic Application -
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193. Antibody Structure and Classes - Answer (click here)
194. Murine, Chimeric, Humanized and Fully Humanized mAbs - Antibody
Structure and Classes - Answer (click here)
195. Antibody Derivatives [F(ab0)2, Fab, Antibody DrugConjugates (ADC)]
and Fusion Proteins - Answer (click here)
196. How Antibodies Function as Therapeutics - Answer (click here)
197. Translational Medicine/Development Process - Answer (click here)
198. Preclinical Safety Assessment of mAbs - Translational
Medicine/Development Process - Answer (click here)
199. Pharmacokinetics - Translational Medicine/Development Process -
Answer (click here)
200. Prediction of Human PK/PD Based on Preclinical Information - Answer
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201. PK/PD in Clinical Development of Antibody Therapeutics - Answer (click
here)
202. Mechanistic Modeling Approaches - Translational
203. Population PK of Monoclonal Antibodies - Answer (click here)
Monoclonal Antibodies in Cancer

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204. Monoclonal Antibodies in Cancer - Answer (click here)
205. Alemtuzumab - Classes of Monoclonal Antibodies: CD Antigens -
Answer (click here)
206. Gemtuzumab - Monoclonal Antibodies in Cancer - Answer (click here)
207. Rituximab, Yttrium-90 (90Y) Ibritumomab Tiuxetan, Iodine-131 (131I)
Tositumomab - Answer (click here)
208. Bevacizumab - Classes of Monoclonal Antibodies: Vascular Endothelial
Growth Factor Inhibitors - Answer (click here)
209. Trastuzumab - Classes of Monoclonal Antibodies: Endothelial Growth
Factor Receptor (EGFR) Inhibitors - Answer (click here)
210. Cetuximab - Classes of Monoclonal Antibodies: Endothelial Growth
211. Panitumumab - Classes of Monoclonal Antibodies: Endothelial Growth
Monoclonal Antibodies in Solid Organ Transplantation

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212. Monoclonal Antibodies in Solid Organ Transplantation - Answer (click
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213. Immunologic Targets: Rational Development/ Use of Monoclonal
Antibodies in Organ Transplant - Answer (click here)
214. Monoclonal Antibodies Administered Pre-Transplant - Answer (click here)
215. Monoclonal Antibodies Administered at the Time of Transplant - Answer
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216. Monoclonal Antibodies Administered Following Transplant - Answer
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217. Muromonab - Specific Agents Used In Solid Organ Transplant - Answer
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218. Interleukin 2 Receptor Antagonists - Specific Agents Used In Solid
Organ Transplant - Answer (click here)
219. Alemtuzumab - Specific Agents Used In Solid Organ Transplant -
Answer (click here)
220. Rituximab - Specific Agents Used In Solid Organ Transplant - Answer
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Monoclonal Antibodies in Anti inflammatory Therapy

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221. Monoclonal Antibodies in Anti inflammatory Therapy - Answer (click here)
222. Arthritides - Monoclonal Antibodies in Anti inflammatory Therapy -
Answer (click here)
223. Infliximab - Arthritides - Monoclonal Antibodies in Anti inflammatory
Therapy - Answer (click here)
224. Etanercept - Arthritides - Monoclonal Antibodies in Anti inflammatory
225. Adalimumab - Arthritides - Monoclonal Antibodies in Anti
inflammatory Therapy - Answer (click here)
226. Abatacept - Arthritides - Monoclonal Antibodies in Anti inflammatory
227. Rituximab - Arthritides - Monoclonal Antibodies in Anti inflammatory
228. Psoriasis: Efalizumab - Monoclonal Antibodies - Answer (click here)
229. Multiple Sclerosis: Natalizumab - Monoclonal Antibodies in Anti
230. Allergic Asthma: Omalizumab - Monoclonal Antibodies in Anti
Recombinant Human Deoxyribonuclease I

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231. Recombinant Human Deoxyribonuclease I - Answer (click here)
232. Protein Chemistry, Enzymology, and Structure - Answer (click here)
233. In Vitro Activity in CF Sputum - Pharmacology - Recombinant Human
Deoxyribonuclease I - Answer (click here)
234. In Vivo Activity in CF Sputum - Pharmacology - Recombinant Human
235. Pharmacokinetics and Metabolism - Pharmacology - Recombinant
Human Deoxyribonuclease I - Answer (click here)
236. Protein Manufacturing and Formulation - Answer (click here)
237. Drug Delivery- Recombinant Human Deoxyribonuclease I - Answer (click
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238. Clinical Use- Recombinant Human Deoxyribonuclease I - Answer (click
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Follicle
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239. Follicle Stimulating Hormone - Answer (click here)
240. Biological Role of Follicle Stimulating Hormone - Answer (click here)
241. Chemical Description of Follicle Stimulating Hormone - Answer (click
here)
242. Production of Recombinant FSH(Follicle Stimulating Hormone) - Answer
(click here)
243. Structural Characteristics of Isohormones - Follicle Stimulating
Hormone - Answer (click here)
244. Biological Properties of Recombinant FSH Isohormones - Answer (click
here)
245. Pharmacokinetic Behavior of Recombinant FSH Isohormones - Answer
(click here)
246. Pharmaceutical Formulations of Follicle Stimulating Hormone(FSH) -
Answer (click here)
247. Clinical Aspects of Follicle Stimulating Hormone(FSH) - Answer (click
here)
Vaccines
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248. Vaccines - Answer (click here)
249. Immunological Principles of Vaccines - Answer (click here)
250. Active Immunization: Generation of an Immune Response - Answer (click
here)
251. Uptake - Immunological Principles of Vaccines - Answer (click here)
252. Activation and Migration - Immunological Principles of Vaccines -
Answer (click here)
253. Antigen Presentation and Lymphocyte Activation - Answer (click here)
254. Adaptive Immune System - Immunological Principles of Vaccines -
Answer (click here)
255. Vaccine Design in Relation with the Immune Response - Answer (click
here)
256. Route of Administration - Immunological Principles of Vaccines -
Answer (click here)
257. Conventional Vaccines: Classification - Answer (click here)
258. Live Attenuated Vaccines - Answer (click here)
259. Non-Living Vaccines: Whole Organisms, Subunit Vaccines - Answer
(click here)
260. Genetically Improved Live Vaccines - Answer (click here)
261. Genetically Improved Subunit Vaccines - Answer (click here)
262. Reverse Vaccinology - Answer (click here)
263. Therapeutic Vaccines - Answer (click here)
264. Pharmaceutical Aspects of Vaccines - Answer (click here)
Dispensing Biotechnology Products Handling Professional

Education and Product Information
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265. Dispensing Biotechnology Products: Handling, Professional Education,
and Product Information - Answer (click here)
266. Pharmacist Reluctance - Answer (click here)
267. Types of Information Needed by Pharmacists - Pharmacist Reluctance -
Answer (click here)
268. Sources of Information for Pharmacists - Answer (click here)
269. The Pharmacist and Handling of Biotech Drugs - Answer (click here)
270. Temperature Requirements - Pharmacist Reluctance - Answer (click here)
271. Storage in Dosing and Administration Devices - Pharmacist Reluctance -
Answer (click here)
272. Storage in IV Solutions and Light Protection - Pharmacist Reluctance -
Answer (click here)
273. Mixing and Shaking - Pharmacist Reluctance - Answer (click here)
274. Travel Requirements - Pharmacist Reluctance - Answer (click here)
275. Preparation of Biotechnology Products - Answer (click here)
276. Administration of Biotechnology Products - Answer (click here)
277. Biogenerics - A Future Consideration? - Answer (click here)
278. Outpatient/Home Care Issues of Biotechnology Products - Answer (click
here)
Economic Considerations in Medical Biotechnology

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279. Economic Considerations in Medical Biotechnology - Answer (click here)
280. The Value of a New Medical Technology - Answer (click here)
281. An Overview of Economic Analysis for New Technologies - Answer (click
here)
Regulatory Issues and Drug Product Approval for

Biopharmaceuticals
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279. Economic Considerations in Medical Biotechnology - Answer (click here)
280. The Value of a New Medical Technology - Answer (click here)
281. An Overview of Economic Analysis for New Technologies - Answer (click
here)
282. Regulatory Issues and Drug Product Approval for Biopharmaceuticals -
Answer (click here)
283. Background Regulatory Issues for Biopharmaceuticals - Answer (click here)
284. Biosimilar and Follow-On Biologics - Answer (click here)
285. Regulatory Routes - Biopharmaceuticals - Answer (click here)

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Pharmaceutical Biotechnology: Fundamentals and Applications

Subject : Pharmaceutical Biotechnology: Fundamentals and

Biophysical and Biochemical Analysis of Recombinant Proteins

Production and Downstream Processing of Biotech Compounds

Formulation of Biotech Products Including Biopharmaceutical

Pharmacokinetics and Pharmacodynamics of Peptide and Protein

Immunogenicity of Therapeutic Proteins

Genomics Other Omics Technologies Personalized Medicine and

Hematopoietic Growth Factors

Interferons and Interleukins

Recombinant Coagulation Factors and Thrombolytic Agents

Monoclonal Antibodies From Structure to Therapeutic

Monoclonal Antibodies in Cancer

Monoclonal Antibodies in Solid Organ Transplantation

Monoclonal Antibodies in Anti inflammatory Therapy

Recombinant Human Deoxyribonuclease I

Dispensing Biotechnology Products Handling Professional

Economic Considerations in Medical Biotechnology

Regulatory Issues and Drug Product Approval for

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