3 Simple Tips For Finding A CRO With IND Application Knowledge The U.S. Food and Drug Administration (FDA) reports having received a higher number…
Biosimilars And Gene Therapy Treatments Are Poised For Growth. Will The Uk Miss Out? On the heels of recent FDA approvals of gene therapies…
Since the enactment of the FDA Safety and Innovation Act (FDASIA) in 2012, the demand for pediatric clinical trials has increased. Pediatric trials are…
About Human Ame (hAME) Studies Before a drug receives marketing approval and is made available to patients, it has to be extensively studied in…
The Antibody-Drug Conjugate Challenge The idea of arming antibodies with other molecular moieties such as toxins or chemotherapeutics dates back to the 1980s, when…
Economic Importance And Financial Impact Of Healthcare In recent years, the pharmaceutical industry has witnessed increased political interest and attention due to the increased…
Studies In Patients Versus Healthy Volunteers Sometimes practical or ethical considerations dictate whether healthy volunteers or patients should be recruited for a particular study….
The Birth Of RNAi The Nobel Prize for the discovery that double-stranded RNAs (dsRNAs) can trigger silencing of complementary messenger RNA sequences was awarded…
The 505(b)(2) Pathway Today, many pharmaceutical companies – generic or innovative, large or small, privately held or publicly traded – are choosing the 505(b)(2)…
Bioequivalence And Bioavailability Trials Are Essential Components Of Generic Or Hybrid Medicinal Product Applications Such studies are also conducted to support formulation selection and…
