- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Justify inter-subject variability in BE study data: CDSCO Panel Tells Alkem on anticancer drug Relugolix
New Delhi: Reviewing the bioequivalence (BE) study report of the anti-cancer drug Relugolix presented by the drug major Alkem Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the Justification regarding significant Inter subject variability in presented BE study data.In addition, the expert...
New Delhi: Reviewing the bioequivalence (BE) study report of the anti-cancer drug Relugolix presented by the drug major Alkem Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the Justification regarding significant Inter subject variability in presented BE study data.
In addition, the expert panel suggested that Alkem Laboratories should submit published pharmacokinetic/pharmacodynamic (PK/PD) data and data on the ratio of serum to CSF concentration.
Furthermore, the committee stated that the firm should submit the minimum effective concentration in CSF required for the pharmacological action of the proposed drug.
This came after Alkem Laboratories presented the BE study report before the committee.
Relugolix is an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer.
Relugolix is used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]) in adult men. Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.
At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the BE study report presented by the Alkem Laboratories.
After detailed deliberation, the committee opined that the firm should submit the following before the committee for further consideration:
1. Justification/clarification regarding significant inter-subject variability in presented BE study data.
2. Published PK/PD data
3. Data on the ratio of serum to CSF concentration
4. Minimum effective concentration in CSF required for pharmacological action of the proposed drug.
Also Read: CDSCO Panel grants AstraZeneca's Protocol Amendment Proposal for Sodium zirconium cyclosilicate
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751