![]() Individual patients, including for emergency use. Requirements for all expanded access uses. Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.Īctive monitoring of conduct and evaluation of clinical trials.įoreign clinical studies not conducted under an IND.Īvailability for public disclosure of data and information in an IND.ĭrugs for Investigational Use in Laboratory Research Animals or In Vitro Testsĭrugs for investigational use in laboratory research animals or in vitro tests.Įxpanded Access to Investigational Drugs for Treatment Use Inspection of investigator's records and reports.ĭisqualification of a clinical investigator.ĭrugs Intended to Treat Life-threatening and Severely-debilitating Illnesses Investigator recordkeeping and record retention. General responsibilities of investigators. Inspection of sponsor's records and reports.ĭisposition of unused supply of investigational drug. Transfer of obligations to a contract research organization.Įmergency research under § 50.24 of this chapter. ![]() Responsibilities of Sponsors and Investigators General requirements for use of an investigational new drug in a clinical investigation.Ĭlinical holds and requests for modification. General principles of the IND submission. Investigational New Drug Application (IND) The most commonly overused combination-analgesics combine non-opioid analgesics with opioids, butalbital and/or caffeine.Charging for investigational drugs under an IND. For this reason, 8.2.5 Combination-analgesic-overuse headache has a separate coding. ![]() They tend to be widely used by people with headache, and are very commonly implicated in 8.2 Medication-overuse headache. Many combination-analgesics are marketed. The combination-analgesic(s) should be specified in parenthesis.Drugs that combine only two non-opioid analgesics (such as acetylsalicylic acid and paracetamol), without an adjuvant, are not considered combination-analgesics since, for the purposes of ICHD-3, both drugs are in the same class. The term combination-analgesic is used specifically for formulations combining drugs of two or more classes, each with analgesic effect (for example, paracetamol and codeine) or acting as adjuvants (for example, caffeine).Regular intake of one or more combination-analgesic medications 1,2 on ≥10 days/month for >3 months.Headache fulfilling criteria for 8.2 Medication-overuse headache.8.3.4 Headache attributed to withdrawal from chronic use of other substanceĨ.2.5 Combination-analgesic-overuse 1 headache Diagnostic criteria:.8.3 Headache attributed to substance withdrawal.8.2.8 Medication-overuse headache attributed to other medication.8.2.7 Medication-overuse headache attributed to unspecified or unverified overuse of multiple drug classes.8.2.6 Medication-overuse headache attributed to multiple drug classes not individually overused.8.2.5 Combination-analgesic-overuse 1 headache.8.2.3.3 Other non-opioid analgesic-overuse headache.8.2.3.2.1 Acetylsalicylic acid-overuse headache.8.2.3.2 Non-steroidal anti-inflammatory drug (NSAID)-overuse headache.8.2.3.1 Paracetamol (acetaminophen)-overuse headache.8.2.3 Non-opioid analgesic-overuse headache.8.1.11 Headache attributed to use of or exposure to other substance.8.1.10 Headache attributed to long-term use of non-headache medication.8.1.9 Headache attributed to occasional use of non-headache medication.8.1.8 Headache attributed to exogenous acute pressor agent.8.1.7.1 Immediate CGRP-induced headache. ![]()
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