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.
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.
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XTalks
JUNE 21, 2024
The ban targets artificial smoke flavorings linked to genotoxicity concerns. Genotoxicity involves damage to genetic material within cells, increasing cancer and inherited disease risks. The EFSA concluded that the majority of assessed smoke flavorings posed genotoxicity risks.
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.
Camargo
APRIL 20, 2021
Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies.
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.
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.
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