The Pharma Data

MAY 3, 2021

According to a Step 4 training presentation on the guideline, the Q3C (R8) Expert Working Group (EWG) review of available toxicity data with 2-MTHF, also known as tert -butylmethyl ether, found no evidence for genotoxicity or reproductive toxicity and no observed effect level in repeat dose toxicity studies involving rats.

Genotoxicity 40

Genotoxicity Regulation Manufacturing Drugs 40

Pharmaceutical Technology

DECEMBER 9, 2022

Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Our comprehensive analytical testing portfolio integrates a broad range of capabilities spanning all stages of drug discovery, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict.

Development 130

Development Manufacturing Production Vaccination 130

Camargo

DECEMBER 22, 2021

In addition to prioritizing programs most closely aligned with sponsor objectives, a portfolio analysis can help prevent a program from failing due to misalignment of the various factors that affect drug development, including clinical, nonclinical, regulatory, scientific, manufacturing, and market dynamics. Fine-Tuning Strategic Assessment.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

FDA Law Blog

OCTOBER 10, 2023

subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation). We find that this information is noteworthy for manufacturers to consider. separate patient labeling). separate patient labeling).

In-Vivo 45

In-Vivo Manufacturing Engineer Genotoxicity 45

Pharmaceutical Technology

JUNE 26, 2022

As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. . Important considerations for drug substance development.

Manufacturing 130

Manufacturing Drugs Production Development 130

XTalks

MAY 13, 2022

Manufacturers must conduct various tests such as stability and extractables and leachables (E&L) testing for packaging materials and enclosures to meet safety and efficacy guidelines. Manufacturing (MFG) Systems/Component/Processes: can ideally involve a USP approach, or a BPOG (BioPhorum Operations Group) approach.

Packaging 98

Packaging Packaging Containment Production 98

The Pharma Data

FEBRUARY 8, 2021

IBRANCE may impair fertility in males and has the potential to cause genotoxicity. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Advise male patients to consider sperm preservation before taking IBRANCE.

HR 52

HR Clinical Trials Clinical Trials Containment 52