News & Analysis on Clinical Trial Services & Contract Research And Development
Under the Controlled Substances Act (CSA) in the United States, drugs that have the potential to be abused are scheduled into one of five Classes or Schedules (CI-V) as controlled substances. The scheduling method makes a distinction for drugs that have abuse potential and are not approved for medical use (i.e., Schedule I) versus drugs that are approved for medical use.
In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs), including: a review of the relevant guidance HPAPI classification systems safety processes...
As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams have decades of experience formulating, testing, and manufacturing pharmaceutical products that...
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