FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
News|Articles|March 1, 2002
- Pharmaceutical Technology-03-02-2002
- Volume 26
- Issue 3
Validation Changes to the USP Assay Method for Ibuprofen Tablets
This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.
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Articles in this issue
over 24 years ago
Outsourcing Outlookover 24 years ago
Developing Custom Adhesive Systems for Transdermal Drug Deliveryover 24 years ago
PDA Task Force Issues Guidelines to Aid Isolator Usersover 24 years ago
Drug Safety Concerns Shape Manufacturing Policyover 24 years ago
Production Information Mangementover 24 years ago
Systematic Troubleshooting for LC/MS/MSAdvertisement
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Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
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.
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
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