Bioequivalency Clinical Trials Containment Production 
Pharmaceutical Technology
OCTOBER 28, 2022
According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.
Camargo
NOVEMBER 11, 2020
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Camargo
DECEMBER 13, 2021
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.
The Pharma Data
FEBRUARY 1, 2021
The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. In clinical trials, the most common adverse events associated with Plegridy were injection site reactions and flu-like symptoms.
The Pharma Data
AUGUST 5, 2020
Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Nor can there be any guarantee that such products will be commercially successful in the future. You should not place undue reliance on these statements.
The Pharma Data
DECEMBER 17, 2020
The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months.
Druggist
MARCH 25, 2021
Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). A box of Cerelle or Cerazette pills comes with three blister blisters, each of which contains 28 mini-pills (note you may be prescribed just one blister = 28 pills). – vomiting. – hair loss.
Expert insights. Personalized for you.
130 
Let's personalize your content