Unit I: Pilot Plant Scale-Up Techniques : Introduction, Objectives and Checklist
Unit I: Pilot Plant Scale-Up Techniques : Significance of personal , space and raw material requirements.
Unit I: Pilot Plant Scale-Up Techniques : Pilot Plant Scale Up Consideration For Laboratory Scale Up
Unit I: Pilot Plant Scale-Up Techniques : Pilot plant scale up consideration for pharmaceutical solid dosage form
Unit I: Pilot Plant Scale-Up Techniques : Pilot plant scale up consideration for pharmaceutical liquid and semi solid dosage form
Unit I: Pilot Plant Scale-Up Techniques : Relevant documentation for pilot plant scale up in pharmaceuticals and SUPAC guideline
Unit I: Pilot Plant Scale-Up Techniques :Platform Technology
Unit I: Pilot Plant Scale-Up Techniques :Question Bank
Unit II: Technology Development & Transfer : Introduction & Terminologies of Technology Transfer
Unit II: Technology Development & Transfer : General Principles and Protocol of Technology Transfer
Unit II: Technology Development & Transfer : Qualification, Validation and Analytical Method Transfer
Unit II: Technology Development & Transfer : Approved Regulatory Agencies and Bodies
Unit II: Technology Development & Transfer : Transfer of Technology Agencies
Unit II: Technology Development & Transfer : Approved Regulatory Agencies and Bodies
Unit II: Technology Development & Transfer : Confidentiality Agreement, Licensing and MOUs
Unit II: Technology Development & Transfer : Question Bank
Unit III: Regulatory Affairs : Regularly Affairs Introduction and Historical Overview
Unit III: Regulatory Affairs : Roles and Responsibilities of Regularly Affairs Department
Unit III: Regulatory Affairs : Drug Development Team and Non clinicals
Unit III: Regulatory Affairs : Pharmacological approach, Metabolism and Toxicology
Unit III: Regulatory Affairs : Investigational New Drug Application (INDA)
Unit III: Regulatory Affairs : Investigational Boucher & NDA
Unit III: Regulatory Affairs : Bioequivalence study and Clinical Trial Protocol
Unit III: Regulatory Affairs : Biostatistics and Data Presentation
Unit III: Regulatory Affairs : Question Bank
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