BDR Pharmaceuticals Gets CDSCO Panel Nod for bioequvalence study of Abiraterone Acetate Oral Suspension
New Delhi: BDR Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study of the anticancer drug Abiraterone Acetate Oral Suspension 1000mg/5ml.
This came after BDR Pharmaceuticals presented the BE protocol in fasting condition before the Committee.
However, the expert panel stated that the protocol needs to include the test of HbA1c, lipid profile, ECG, CBC, LFT, and KFT at the time of screening and completion of Period I and Period II. Further, it added that the sample size should be increased to 38 subjects.
In addition, the expert panel stated that the firm has to justify the use of Abiraterone Acetate Oral Suspension 1000 mg/5 ml as the suspension is not approved anywhere in the world and Abiraterone Tablets 250 mg/500 mg are approved in the country.
Abiraterone is an antiandrogen used in the treatment of metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer. Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumor tissues, to regulate androgen biosynthesis.
At the recent SEC meeting for oncology held on 10th December 2024, the expert panel reviewed the BE protocol. After detailed deliberation, the committee recommended the conduct of the BE study in fasting conditions with the following:
1) Protocol needs to include the test of HbA1c, lipid profile, ECG, CBC, LFT, and KFT at the time of screening and completion of Period I and Period II. Further, the sample size should be increased to 38 subjects.
2) Further, the firm has to justify the use of Abiraterone Acetate Oral Suspension 1000 mg/5 ml, as the suspension is not approved anywhere in the world and Abiraterone Tablets 250 mg/500 mg are approved in the country.
