None listed
Conditions
Interventions
Control Intervention1: NA: NA
Sponsors
Manipal Academy of Higher Education
Eligibility
Inclusion criteria
Inclusion criteria: 1. Qualitative analysis Experienced professionals (greater than 5 years) in all the above fields either innovator or generic drug industries. 2. Quantitative analysis Professionals in complex generic drug formulation development departments, CROs, regulatory departments, and physicians.
Exclusion criteria
Exclusion criteria: A. Qualitative analysis 1. Junior staff or low-experienced personnel (less than 5 years) in all the above-mentioned departments are excluded from the study. 2. The participant who is not voluntarily participating or withdrawing their participation in any stages of the study are excluded. 3. The five-year experienced professionals who are not willing to be participants in this study are not considered for the study. B. Quantitative analysis 1. The personnel who are already involved in the qualitative study are eliminated 2. Industrial professionals who don’t have a direct relation with any stages of complex generics as well as other health care professionals like nurses, pharmacists etc 3. The participants who are not voluntarily participating in the study are excluded 4. The participants who do not answer the entire questionnaire are removed from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Detecting the differences in regulatory guidelines, and the current market scenario of complex generics (CG). 2. To determine the most challenging factors affecting the formulation department and CROs. 3. To analyze the critical challenges faced by regulatory professionals for the approval process. 4. To detect the ADR as well as the concerns about the CG from the perception of the physician. 5. Highlighting the need for a proper guideline and finally framing a new guideline draft for CG. Timepoint: 1. 5 months 2. 14 months 3. 7 months 4. 7 months 5. 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Framing regulatory guidelinesTimepoint: 3 years | — |
Countries
India
Contacts
Public ContactAmatha S
Manipal College of Pharmaceutical Science
Outcome results
None listed