The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
News|Articles|February 2, 2005
- Pharmaceutical Technology-02-02-2005
- Volume 29
- Issue 2
Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products
The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.
Advertisement
Articles in this issue
over 21 years ago
Correcting the Courseover 21 years ago
February 2005over 21 years ago
Good Work and True: USP Prepares for Convention 2005over 21 years ago
Contract Manufacturers Getting Squeezedover 21 years ago
In the Spotlight-February 2005over 21 years ago
Emerging Analytical Technology: Moving from the Lab to the Lineover 21 years ago
Drug Safety Fears May Limit Reimporting and Shape R&Dover 21 years ago
In Defense of USP Singlet TestingAdvertisement
Related to this article
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Pauric Bannigan, Intrepid Labs, explains how physics-informed machine learning aids formulation and why regulators still want experimental data.
Advertisement
Advertisement