Bcmas terms - Study guides, Class notes & Summaries

BCMAS Terms (Terms Used Throughout BCMAS Text)BCMAS Terms (Terms Used Throughout BCMAS Text)BCMAS Terms (Terms Used Throughout BCMAS Text)Abbreviated New Drug Application - ANSWER-Application to be submitted for FDA approval of generic drugs, where data about bioequivalence or therapeutic equivalence must be clearly demonstrated. Companies are allowed to submit ANDA once the patents of bioequivalent brand-name drugs have expired. Active Pharmaceutical Ingredients (API's) - ANSWER-Raw chemica...

BCMAS Terms (Terms used throughout BCMAS) Questions and Answers 100% Solved Abbreviated New Drug Application Correct answer Application to be submitted for FDA approval of generic drugs, where data about bioequivalence or therapeutic equivalence must be clearly demonstrated. Companies are allowed to submit ANDA once the patents of bioequivalent brand-name drugs have expired. Active Pharmaceutical Ingredients (API's) Correct answer Raw chemical materials that are used to manufacture ...

BCMAS Terms Abbreviated New Drug Application - answerApplication to be submitted for FDA approval of generic drugs, where data about bioequivalence or therapeutic equivalence must be clearly demonstrated. Companies are allowed to submit ANDA once the patents of bioequivalent brand- name drugs have expired. Active Pharmaceutical Ingredients (API's) - answerRaw chemical materials that are used to manufacture drugs Adjuvant Therapy - answerAdditional treatment to the main or initial treatme...

BCMAS TERMS QUESTIONS AND ANSWERS

BCMAS Exam Questions With Verified Answers Most commonly used study design: - answerparallel Under what conditions can a pharma company provide financial support for conferences and CME? - answerThe grants/contributions are separate from other company funds The company has had no control over the selection of content, faculty, or venue Not required by ADR reporting: - answercareful selection of clinical trial participants Required: -recognition of events -safety signals are identified a...