Industrial Pharmacy is one of the subjects in the 7th semester of B Pharmacy. This course is designed to impart fundamental knowledge on pharmaceutical product commercialization from laboratory to market. Nirali Books are one of the best selling books most widely considered in B Pharmacy Education. Below are the links are given to Industrial Pharmacy Nirali for B Pharmacy 7th Semester format for Industrial Pharmacy.
Industrial Pharmacy ebook 7th Semester Free Download
Industrial Pharmacy PDF 7th Semester
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Specs of Industrial Pharmacy Nirali ebook:
This ebook comprises of following features:
- UNIT-I
- Pilot plant scale up techniques: General considerations - including significance of personnel requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to Platform technology
- UNIT-II
- Pilot plant scale up techniques: General considerations - including significance of personnel requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to Platform technology
- UNIT-III
- Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies
- UNIT-IV
- Quality management systems: Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by design, Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
- UNIT-V
- Quality management systems: Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by design, Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Overview
- With some weird diagrams, Industrial Pharmacy Nirali still manages to explain the mechanism of drugs action with flowcharts and images.
Industrial Pharmacy Nirali PDF Free Download link is given below you can download the ebook directly by clicking the link given below.
Download Industrial Pharmacy Nirali 5MB
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