DrugBank

OCTOBER 30, 2024

This lets you focus on what matters most: driving meaningful results in drug research and development. Your Need for Accessible, High-Quality Data—Solved Pharmaceutical research and healthcare innovation demand timely access to comprehensive, up-to-date data.

Production 98

Production Clinical Trials Packaging Compliance 98

Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. that are fast progressing clinical trials. that are fast progressing clinical trials. TYVYT® is the only PD-1 inhibitor included in the NRDL.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

DrugBank

MARCH 22, 2024

These data sources are known for being highly referenced and usable for specific research activities; further yet, a number of recognizable open sources, along with their identifiers, are considered industry standard resources. Limited coverage : Open source ontologies and datasets have a very narrow and particular focus on what they cover.

Licensing 98

Licensing Licensing Research Clinical Trials 98

Agency IQ

JUNE 9, 2023

The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP). Additionally, the smaller potential customer base may provide an insufficient return on the investment into research.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

JUNE 7, 2024

The BIMO program’s scope covers all of the FDA’s product Centers – including CDER, CBER, CDRH, CFSAN as well as the Centers for Tobacco Products and Veterinary Medicine. During this timeframe on-site inspections were conducted if deemed mission-critical by both the product center and ORA.”

FDA 40

FDA Compliance Regulations Production 40