This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Patient-Centric Approaches: The shift towards patient empowerment has revolutionized the way pharma brands communicate. Television and Print: While digital is dominant, TV and magazines still play a role, especially for older audiences. Campaigns now prioritize storytelling and empathy.
Oligos generally have excellent stability in aqueous solutions, and lyophilized oligos are dissolved in aqueous formulation buffers for preparation of the final dosage form anyway. You may unsubscribe from these ISPE communications at any time. Cell & Gene Therapy. Unlock Access to Member-Only Content. Company Name.
Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,
Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,
End-to-End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation.” Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. Lakerveld, B.
Its Pharmaceutical Education & Research Center (PERC) is a US Food and Drug Administration (FDA)-registered, cGMP-compliant, single-source CRO equipped with the latest equipment and technologies, for most dosage forms, found in the pharmaceutical industry. You may unsubscribe from these ISPE communications at any time.
The information required in these declarations include product information (name, strength, dosage form), manufacturer, packager and license holder, and drug product manufacturing site name and country. In Chile, it is required to include specific tests in the local drug product specification, depending on the dosage form.
The use of structured content and data management in CMC regulatory submissions could potentially provide a direct link to proactively manage risks in the supply chain and communicate with regulators. Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers: Program Announcement.”
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content