Clinical Pharmacology Marketing Pharmacokinetics 
Drug Patent Watch
DECEMBER 30, 2024
This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. New Drug Application (NDA) : Needed for marketing approval of new drugs. Freyr Solutions.
Drug Target Review
APRIL 7, 2025
As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics. Rodrigues AD.
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The Premier Consulting Blog
JULY 31, 2024
In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. food effect, smoking, and drug-drug interactions) on drug exposure and response.
Alta Sciences
OCTOBER 30, 2023
35: Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs Mainly driven by oncological research, the demand for highly potent active pharmaceutical ingredients (HPAPIs) has increased over the past 10 years—with over 25% on the market formulated with HPAPIs. Read or listen now. Watch it now.
The Premier Consulting Blog
SEPTEMBER 11, 2024
The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. Human factors. The new formulation resulted in a drug product that was very viscous.
Agency IQ
SEPTEMBER 15, 2023
Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments. hours, the drug is no longer physiologically active.
Agency IQ
JULY 28, 2023
For example, a letter from Massachusetts Senator Ed Markey called on FDA to “enhance post-market surveillance of opioids, including by conducting regular, formal reviews of opioid approvals,” among other regulatory activities. Read AgencyIQ’s backgrounder on the FDA’s recent responses to the opioid crisis here. ].
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