Biostatistics is the application of statistics in the development and use of therapeutic drugs and devices in humans and animals. Page 7.
What is Biostatistics? Biostatistics is the application of statistics in the development and use of therapeutic drugs and devices in humans and animals.
Division of Biometrics I
James Hung, Ph.D., Director Sue Jane Wang, Ph.D., Deputy Director Focuses on the development and regulatory evaluation of:.
1) Anesthesia, Analgesia, and Addiction Products.
2) Neurology Products.
3) Psychiatric Products.
4) Medical Imaging Products
Division of Biometrics II
Mark Rothmann, Ph.D., Director Yun Wang, Ph.D., Deputy Director Focuses on the development and regulatory evaluation of:.
1) Cardiology and Nephrology Products.
2) General Endocrinology Products.
3) Diabetes, Lipids and Obesity Products.
4) Pediatrics and Maternal Health Products
Division of Biometrics III
Laura Lee Johnson, Ph.D., Director Vacant, Deputy Director Focuses on the development and regulatory evaluation of:.
1) Dermatology and Dentistry Products.
2) Gastroenterology Products.
3) Hepatology and Nutrition Products.
4) Pulmonology, Allergy, and Critical Care Products.
5) Rheumatology and Transplant Medicine Products.
6) Patient Experience Data
Division of Biometrics IV
Lei Nie, Ph.D., Director Daphne Lin, Ph.D., Deputy Director Focuses on the development and regulatory evaluation of:.
1) Anti-infective Products.
2) Antiviral Products.
3) Rare Disease and Medical Genetics Products.
4) Urology, Obstetrics, and Gynecology Products.
5) Ophthalmology Products
Division of Biometrics V
Shenghui Tang, Ph.D., Director Vacant, Deputy Director Focuses on the development and regulatory evaluation of:.
1) Oncology Products for Solid Tumors
Division of Biometrics Vi
Yi Tsong, Ph.D., Director Atiar Rahman, Ph.D., Deputy Director Provides statistical review of and consultation for:.
1) Pharmacology/toxicology.
2) Chemistry, manufacturing, and controls (CMC) evaluations.
3) Drug abuse potential and abuse deterrence studies.
4) Analytical biosimilarity studies.
5) QT/QTc studies.
6) Other non-clinical studies
What We Do
Ensure the safety and effectiveness of new drugs, therapeutic biologics, generic drugs, over the counter products, and biosimilar products through pre-market review of drug development programs.
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