Food and Drug Administration

Pharmaceutical Science Advisory Committee

Process Analysis Technology Subcommittee

March 13, 2003


Drug Product Quality "Pharmaceutical cGMPs for the 21st Century," Helen Winkle, FDA (HTM) (PPT)

Dose Content Uniformity for Aerosol Products, Dr. Wallace Adams, PhD (HTM) (PPT)

Parametric Tolerance Interval (PTI) Test for Improved Control of Delivered Dose Uniformity (DDU) in Orally Inhaled and Nasal Drug Products (OQNDP), Bo Olsson, AstraZeneca (HTM) (PPT)

An Assessment of IPAC-RS' Proposal, Dr. Walter Hauck, PhD (HTM) (PPT)

Errata (HTM) (PPT)

Bioavailability (BA) and Bioequivalence (BE) of Endogenous Substance Drug Products, Dr. Dale Conner, PharmD, FDA (HTM) (PPT)

Endogenous Substance Bioavailability and Bioequivalence: Levothyroxine Sodium Tablets, Dr. Steven Johnson, PharmD, FDA (HTM) (PPT)

Potassium Chloride Tablets & Capsules - Documentation of BE, Dr. Barbara Davit, PhD, FDA (HTM) (PPT)

Operating Characteristic Curve, Yi Tsong (HTM) (PPT)

Bioequivalence and Baseline Correction of Endogenous Substances - Case Study: Levothyroxine Sodium Products, Dr. Leonard Wartofsky, MD and G Granneman, PhD, Washington hospital Ctr. (HTM) (PPT)

Rapid Response Team, Dr. Nakissa Sadrieh, PhD (HTM) (PPT)

Open Public Hearing

The Need for Precise L-Thyroxine Dosing, Dr. James Hennessey, MD, Brown Medical School (HTM) (PPT)

American Association of Clinical Endocrinologists, Dr. Carlos Hamilton, JR., MD, FACE, Univ. of Texas Health Science Ctr. (HTM) (PPT)

L-T4 Bioequivalence: Potential Impact on IQ in Babies With Congenital Hypothyroidism, Dr. Rosalind Brown, MD, Harvard Medical School (HTM) (PPT)

A 62 Year Old Woman Presented With Classic Symptoms of Hypothyroidism, Dr. Bryan Haugen, MD (HTM) (PPT)

Levothyroxine Suppressive Therapy in Thyroid Cancer, Dr. R. Tuttle, MD, MEmorial Sloan Kettering Cancer Ctr. (HTM) (PPT)