Saddam Nawaz

Jun 6, 2024 | biosimilardevelopment.com | Saddam Nawaz

Get more biosimilar development insight with our FREE newsletter Newsletter | June 6, 2024 Webinar: Key Elements of Process and Analytical Development to Support Biologics Tech TransferIn this webinar our expert panel discusses the intricacies of technology transfer, drawing from real-life case studies. Investigate critical components for success, risk assessment, and effective mitigation strategies.

May 30, 2024 | pharmaceuticalonline.com | Saddam Nawaz |Jenny Minigh |inSeption Group

Webinar: Dry Powder Inhalable Vaccines for Shelf Stability and Global AccessThere is a significant need for shelf-stable vaccines that are simpler to store and distribute. Vaccines require cold chain distribution and to be stored in a refrigerator or freezer. This webinar will look at the formulation of vaccines with dry powder respiratory delivery in mind, and manufacturing considerations for dry powder inhaled vaccines. Click here to learn more.

May 28, 2024 | laboratorynetwork.com | Saddam Nawaz |Tim Sandle

By Md. Saddam Nawaz, ACI HealthCare Ltd. The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3. By Tim Sandle, Ph.D.Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

May 16, 2024 | outsourcedpharma.com | Saddam Nawaz |Louis Garguilo

By Md. Saddam Nawaz, ACI HealthCare Ltd. In response to shifting pharmaceutical research and regulatory standards, the FDA released a draft guidance titled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This guidance emphasizes the crucial role of maintaining data integrity throughout study life cycles and provides extensive recommendations for applicants and testing site management.

Jun 15, 2023 | clinicalleader.com | Saddam Nawaz |Ankit Tyagi |Donald E. Palmer |Glenn Boyet

Considerations For How To Smoothly Run A Clinical Trial Biopharmaceutical sponsors have consistently faced challenges in clinical trials, including difficulty with patient recruitment and retention, maintaining a favorable risk profile, and the pressure to be the first to market their products.