PerkinElmer

NOVEMBER 12, 2020

In drug development, assays are test systems that gauge the effects of chemical compounds on certain cellular, molecular, or biochemical processes. They are a vital step in modern pharma research that pushes drugs to market faster. These are just three of the steps to take toward reliable and replicable assay development.

Assay Development 52

Assay Development Drug Development Research Drugs 52

Alta Sciences

AUGUST 21, 2023

Efficient Characterization of ADME A critical feature of the bioanalytical platform selected for a drug development program is how well it characterizes the ADME (absorption, distribution, metabolism, excretion) of your molecule of interest. Image blog-thumbnail-bioanalytical-platform-selection_0.png

Assay Development 52

Assay Development Pharmacokinetics Drug Development Drugs 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Similar to the OTAT town hall meeting in September, potency assay requirements and pitfalls were discussed.

Therapies 59

Therapies Engineering Production FDA 59

The Premier Consulting Blog

OCTOBER 26, 2022

Definition of the manufacturing process description The Parenteral Drug Association defines the MPD as: A tool used to assist in execution of risk assessments, in the development of the Control Strategy, and for transfer of the process for commercial manufacturing.

Production 40

Production Assay Development Clinical Supply Clinical Development 40