| Name | Download | Download Size |
|---|---|---|
| Lecture Note | Download as zip file | 60M |
| Sl.No | Chapter Name | MP4 Download |
|---|---|---|
| 1 | Courses Overview | Download |
| 2 | Overview of Indian regulatory system | Download |
| 3 | Overview of Drugs & Cosmetics Act and Rules thereunder | Download |
| 4 | Overview of New Drugs and Clinical Trials Rules, 2019 | Download |
| 5 | PRE-CLINICAL DATA REQUIREMENTS | Download |
| 6 | RULES GOVERNING CLINICAL TRIALS | Download |
| 7 | Phases of clinical trial, forms, and fees | Download |
| 8 | Regulatory pathway and data requirements for NDCT, 2019 | Download |
| 9 | BA/BE study and study centers: Legal provisions | Download |
| 10 | Guidelines to conduct BA/BE studies | Download |
| 11 | Ethics Committee registration and re-registration | Download |
| 12 | Ethical Considerations | Download |
| 13 | Good Clinical Practice | Download |
| 14 | Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in India | Download |
| 15 | Requirements for import/ manufacture of new drug/ IND for sale/ distribution & unapproved new drug for patients | Download |
| 16 | Important issues | Download |
| 17 | Special concern | Download |
| 18 | Clinical trial related guidelines (NDCT Rules) | Download |
| 19 | Content of Proposed Clinical Trial Protocol | Download |
| 20 | Content of a Clinical Trial Report | Download |
| 21 | Post Marketing Assessment & Clinical Trial Compensation | Download |
| 22 | Common observations during submission of CT/BA/BE protocol | Download |
| 23 | Common observations during CT/BA/BE centre inspections | Download |
| 24 | Drug development process: Overview | Download |
| 25 | Salient feature of NDCT 2019 - what's new in NDCT? | Download |
| 26 | Online Submission 23A: SUGAM | Download |
| 27 | ONLINE SUBMISSION (CTRI) | Download |
| 28 | TABLES GIVEN IN NDCT 2019 AND ITS CONTENT | Download |
| Sl.No | Chapter Name | English |
|---|---|---|
| 1 | Courses Overview | Download Verified |
| 2 | Overview of Indian regulatory system | Download Verified |
| 3 | Overview of Drugs & Cosmetics Act and Rules thereunder | Download Verified |
| 4 | Overview of New Drugs and Clinical Trials Rules, 2019 | Download Verified |
| 5 | PRE-CLINICAL DATA REQUIREMENTS | Download Verified |
| 6 | RULES GOVERNING CLINICAL TRIALS | Download Verified |
| 7 | Phases of clinical trial, forms, and fees | Download Verified |
| 8 | Regulatory pathway and data requirements for NDCT, 2019 | Download Verified |
| 9 | BA/BE study and study centers: Legal provisions | Download Verified |
| 10 | Guidelines to conduct BA/BE studies | Download Verified |
| 11 | Ethics Committee registration and re-registration | Download Verified |
| 12 | Ethical Considerations | Download Verified |
| 13 | Good Clinical Practice | Download Verified |
| 14 | Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in India | Download Verified |
| 15 | Requirements for import/ manufacture of new drug/ IND for sale/ distribution & unapproved new drug for patients | Download Verified |
| 16 | Important issues | Download Verified |
| 17 | Special concern | Download Verified |
| 18 | Clinical trial related guidelines (NDCT Rules) | Download Verified |
| 19 | Content of Proposed Clinical Trial Protocol | Download Verified |
| 20 | Content of a Clinical Trial Report | Download Verified |
| 21 | Post Marketing Assessment & Clinical Trial Compensation | Download Verified |
| 22 | Common observations during submission of CT/BA/BE protocol | Download Verified |
| 23 | Common observations during CT/BA/BE centre inspections | Download Verified |
| 24 | Drug development process: Overview | Download Verified |
| 25 | Salient feature of NDCT 2019 - what's new in NDCT? | Download Verified |
| 26 | Online Submission 23A: SUGAM | Download Verified |
| 27 | ONLINE SUBMISSION (CTRI) | Download Verified |
| 28 | TABLES GIVEN IN NDCT 2019 AND ITS CONTENT | Download Verified |
| Sl.No | Language | Book link |
|---|---|---|
| 1 | English | Download |
| 2 | Bengali | Not Available |
| 3 | Gujarati | Not Available |
| 4 | Hindi | Not Available |
| 5 | Kannada | Not Available |
| 6 | Malayalam | Not Available |
| 7 | Marathi | Not Available |
| 8 | Tamil | Not Available |
| 9 | Telugu | Not Available |