{"id":194,"date":"2021-06-20T02:35:08","date_gmt":"2021-06-20T02:35:08","guid":{"rendered":"https:\/\/thepreparedpharmacist.com\/?p=194"},"modified":"2021-06-22T03:29:00","modified_gmt":"2021-06-22T03:29:00","slug":"equivalence-and-substitution","status":"publish","type":"post","link":"https:\/\/thepreparedpharmacist.com\/?p=194","title":{"rendered":"Equivalence and Substitution"},"content":{"rendered":"\n

Regulations fall within the jurisdiction of the individual states.<\/span><\/strong><\/h3>\n\n\n\n

Pharmaceutical equivalence:<\/strong> <\/span> same active ingredient, same dosage form, same route of administration, identical in dosage strength or concentration, may contain different excipients\u00a0<\/h3>\n\n\n\n

Therapeutic equivalence:\u00a0<\/span> <\/strong>pharmaceutical equivalence and bioequivalent\u00a0<\/h3>\n\n\n\n

Bioequivalence | ADME<\/span><\/strong><\/h3>\n\n\n\n

A<\/span><\/strong> = absorption<\/p>\n\n\n\n

D<\/span><\/strong> = distribution<\/p>\n\n\n\n

M<\/span><\/strong> = metabolism<\/p>\n\n\n\n

E<\/span><\/strong> = elimination\u00a0<\/p>\n\n\n\n

The manufacturer must submit graphs to the FDA illustrating the two products containing the same drug have similar blood concentration vs. time curves, including:\u00a0<\/strong><\/h3>\n\n\n\n

Time to peak<\/p>\n\n\n\n

Peak concentrations<\/p>\n\n\n\n

Area under the curve (AUC)<\/p>\n\n\n\n

References<\/span><\/strong><\/h3>\n\n\n\n

Approved Drug Products with Therapeutic Equivalence Evaluations <\/em>aka The Orange Book<\/p>\n\n\n\n

The Electronic Orange Book (internet version)<\/p>\n\n\n\n

United States Pharmacopeia Dispensing Information (USP\/DI) Volume III <\/em>plus supplements <\/p>\n\n\n\n

Facts and Comparisons, Inc Approved Bioequivalence Codes <\/p>\n\n\n\n

FDA\u2019s Internet Website http:\/\/www.fda.gov<\/a><\/p>\n\n\n\n

Drugs marketed before 1938 are not required to be in The Orange Book.<\/strong><\/p>\n\n\n\n

A Rated<\/span><\/u><\/strong><\/h3>\n\n\n\n

Bioequivalent to the innovator\u2019s drug product\u00a0<\/p>\n\n\n\n

Therapeutically equivalent to the brand name or reference product<\/p>\n\n\n\n

A-rated products may be substituted for one another.<\/p>\n\n\n\n

B Rated<\/span><\/u><\/strong><\/h3>\n\n\n\n

NOT bioequivalent to the innovator\u2019s drug product\u00a0<\/p>\n\n\n\n

B-rated products may not be substituted for one another.<\/p>\n\n\n\n

Generally, a tablet cannot be substituted for a capsule, an ointment for a cream.  Most sustained-release or controlled-release are not interchangeable. <\/p>\n\n\n\n

AB Rated<\/span><\/u><\/strong><\/h3>\n\n\n\n

Previously not considered to be bioequivalent and now organized into bioequivalence groups (AB1, AB2, AB3, etc)<\/p>\n\n\n\n

Must have the same number or lack of number to be bioequivalent\u00a0<\/p>\n\n\n\n

Cannot substitute an AB1 product for a product designated as AB2<\/p>\n\n\n\n

The Federal government has not passed regulations limiting the substitution of these products although a few states have.<\/span> <\/h3>\n\n\n\n

Examples:<\/strong><\/p>\n\n\n\n

Carbamazepine<\/p>\n\n\n\n

Digoxin<\/p>\n\n\n\n

Levothyroxine<\/p>\n\n\n\n

Lithium<\/p>\n\n\n\n

Phenytoin<\/p>\n\n\n\n

Theophylline<\/p>\n\n\n\n

Valproic acid<\/p>\n\n\n\n

Warfarin<\/p>\n\n\n\n

Checkout our self-guided courses and instant download study guides on Teachable for Texas, Iowa, Maryland and federal law!<\/h2>\n\n\n\n
\n
Link to Teachable Site<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Regulations fall within the jurisdiction of the individual states. Pharmaceutical equivalence: same active ingredient, same dosage form, same route of administration, identical in dosage strength or concentration, may contain different excipients\u00a0 Therapeutic equivalence:\u00a0 pharmaceutical equivalence and bioequivalent\u00a0 Bioequivalence | ADME A = absorption D = distribution M = metabolism E = elimination\u00a0 The manufacturer must … <\/p>\n

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